This section of the FEDERAL REGISTER
contains documents other than rules orproposed rules that are applicable to thepublic. Notices of hearings and investigations,committee meetings, agency decisions andrulings, delegations of authority, filing ofpetitions and applications and agencystatements of organization and functions areexamples of documents appearing in thissection.NoticesFederal Register26249 
Vol. 88, No. 82 
Friday, April 28, 2023 
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. 
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 
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1See 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). 
2When 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. 
3On 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). 
4See Texas Food Industry Association v. Espy, 
870 F. Supp. 143 (1994). 
5Michael 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. 6CSPI 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 products based on the assumption that 
ordinary cooking is generally sufficient to destroy the pathogens.
12The 
exceptions are Escherichia coli O157:H7 (E. coli O157:H:7)
3and 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 
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).
5In 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. 
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.
6FSIS denied the 
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(2)(a) and 21 U.S.C. 453(g)(1) and (2)(a).’’ FSIS final 
response July 31, 2014. 
7FSIS final response to petition #11–06, p. 1. 
8CSPI 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. 
9FSIS 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. 10FSIS 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. 
11Marler 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. 
12FSIS 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. 
13United 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. 14CSPI 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. 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.’’
7The 
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. 
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.
8Based 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.’’
9The 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 
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.
11The 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. 
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.
12The response noted that, as 
announced in October 2021,13FSIS 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. 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.
14With 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. 
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 
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15FSIS 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. 16Smith, 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. 17CDC National Outbreak Reporting System 
available at: https://www.cdc.gov/nors/index.html . 
18Smith 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. 
19Smith, K. et al. (2008). 
20Smith, K. et al. (2008). 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.
15The 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. 
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.
16In addition, NRTE 
breaded stuffed chicken products have been associated with a number of Salmonella illness outbreaks in the 
United States. 
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)
17or 
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). 
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.
18In 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.
19Of 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 °F’’ to the cooking 
instructions on the back of the package. 
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 
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21Response 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. 
22Smith, K. et al. (2008). 
23FSIS Recall Release: Indiana Firm Recalls 
Frozen Stuffed Chicken Entrees Associated with Illnesses (March 10, 2006). 
24FSIS Issues Public Health Alert for Frozen, 
Stuffed, Raw Chicken Products (July 2006). 25Smith, K. et al. (2008). 
26Letter to industry about the safe handling 
labeling of uncooked, breaded, boneless poultry 
products (March 2006) at: https://www.fsis.usda.gov/guidelines/2006-0007. 27Response 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. 
28Labeling Policy Guidance Uncooked, Breaded, 
Boneless Poultry Products (April 2006) at: https:// 
www.fsis.usda.gov/guidelines/2017-0001. 
29FSIS 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. 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.
21In 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. 
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.
22The 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.
23Because 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 °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. 
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.
25Two 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. 
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.
26The 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. 
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.
27The 
NACMCF recommended, among other 
things, that consumers should be advised to cook these products to a single minimum internal temperature of 165°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 °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 
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.
29Specifically, 
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. 
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 °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 
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30Minnesota 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. 
31FSIS Public Health Alert, March 29, 2008. 
32The 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). 
33MDH News Release; Salmonella cases linked to 
raw, frozen chicken entrees (Oct 8, 2008). 
34FSIS outbreak investigation case 2009–02. 
35FSIS outbreak investigation case 2009–02. 36FSIS Issues Public Health Alert, October 3, 
2008. 
37FSIS outbreak investigation case 2009–23. 
38FSIS outbreak investigation case 2009–43. 
39FSIS outbreak investigation case 2013–17. 40An HAV task is a verification task performed 
by IPP focusing on establishments’ hazard analyses, pre-requisite programs, and other supporting documentation. 
41FSIS Notice 31–14, Supplemental Instructions 
for Performing the Hazard Analysis Verification Task in Establishments that Produce NRTE Stuffed Poultry Products (June 30, 2014). 
42Salmonella cases linked to raw, frozen chicken 
entrees (October 23, 2014). Press release by Minnesota Department of Health/Minnesota Department of Agriculture. 
43FSIS 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. 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)
32at the establishment. 
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.
33MDH 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:-.
34An 
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. 
After the investigation was initiated, 
FSIS issued a PHA due to concerns about illnesses that may be associated 
with NRTE breaded stuffed chicken 
products.
36The 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. 
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. 
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. 
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.
39The 
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. 
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
40at establishments that 
produced NRTE breaded stuffed chicken products.
41The 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. 
In a separate investigation in August 
2014, six Salmonella Enteritidis 
illnesses in Minnesota were associated with NRTE breaded stuffed Chicken Kiev products.
42The 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.
43The 
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 
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44FSIS 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. 
45Minnesota Department of Health: Salmonella 
cases linked to raw, frozen, stuffed chicken products (July 2, 2015) at: https://content.govdelivery.com/accounts/MNMDH/ bulletins/10d1df0. 
46CDC: 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. 
47Aspen 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. 48FSIS 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. 
49Aspen 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. 
50CDC: 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.. 
51FSIS outbreak ID 2015–12. 
52Barber 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. 53FSIS outbreak investigation case 2016–06. 
54NOIE Establishment P–1358, July 10, 2015. 
55NOIE Establishment P–276, July 10, 2015. 
56FSIS Notice 15–16, Profile Update In 
Establishments That Produce Not-Ready-To-Eat Stuffed Chicken Products That Appear Ready-To Eat (February 18, 2016). 
57The 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. 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°F. 
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 45One of the outbreaks included 
five cases from Minnesota with illness onset dates from May 9, 2015, through July 22, 2015.
46Two 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°F, and one case patient stated that 
they were not aware that the product was raw and cooked it in a microwave. 
In response to the outbreak, the 
establishment voluntarily recalled approximately 1,978,608 pounds of product in July 2015.
47In 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.
48In 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.
49The 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 °F as measured by a 
food thermometer and included icons and illustration that emphasized these messages. 
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.
50Information available 
from eight case patients indicated that seven of the eight cooked the product in 
a conventional oven and one used a toaster oven.
51In 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.
52The 
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 °F as measured by a 
food thermometer and included icons and illustration that emphasized these messages. 
In 2016, 5 Salmonella Enteritidis 
cases associated with NRTE breaded stuffed chicken were reported in Minnesota.
53Three 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. 
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 55FSIS 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. 
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.
56After IPP updated the PHIS 
profiles, FSIS used the information to schedule a Public Health Risk Evaluation (PHRE)
57and, if necessary, 
an FSA at these establishments. FSIS also captured information concerning 
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58Information 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. 
59National 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). 
60Subcommittee #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). 61National 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. 
62Attachment 1, National Chicken Council 
petition #16–03. 
63Letter 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. 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 
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.
59The 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.
60The 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. 
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.
61The 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.
62The 
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.
63The 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. 
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 
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64Final 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. 
65Figure 2–2 Packaging for NRTE Chicken 
Product Used in Meal Preparation Study. 66Marshall, 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. 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.
64FSIS 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 °F as measured by a 
food thermometer.
65 
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 °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 °F, and 75 percent of 
those participants successfully cooked the chicken breast to 165 °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.
66In 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 
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67USDA, 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. 
68CDC: Salmonella Outbreak Linked to Raw 
Frozen Breaded Stuffed Chicken Products (October 13, 2021) at: https://www.cdc.gov/salmonella/ enteritidis-06-21/index.html. 
69FSIS 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. 70Serenade 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. 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. 
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 68Epidemiologic, 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. 
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 °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 °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.
69FSIS 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 
TABLE 1—S UMMARY OF SALMONELLA OUTBREAK INVESTIGATIONS ASSOCIATED WITHNRTE B READED 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 
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71National 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. 
722021 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. 73National 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. TABLE 1—S UMMARY OF SALMONELLA OUTBREAK INVESTIGATIONS ASSOCIATED WITHNRTE B READED STUFFED CHICKEN  
PRODUCTS 1998–2021—Continued 
Year Serotype Illnesses Hospitalization Recall/PHA 
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.
71The 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.
72In 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. 
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 °F as measured using a 
food thermometer.
73The 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. 
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 
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74United 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. 
75Rimet, 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. 
76Sampling Results for FSIS-Regulated Products. 
Available at: https://www.fsis.usda.gov/science- data/sampling-program/sampling-results-fsis- regulated-products. 
77FSIS 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. 
78Codex 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. 
79Kim J–W and Slavik M.F. 1996. 
Cetylpyridinium Chloride (CPC) treatment on poultry skin to reduce attached Salmonella. J. Food 
Prot. 59: 322–326. 
80Wu 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. 
81FSIS Guidance for Controlling Salmonella in 
Poultry (June 2021) pp. 59–60. Available at: https:// 
www.fsis.usda.gov/guidelines/2021-0005. 
82FSIS 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. 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 
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.
75Salmonella 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.
76This difference is most likely because of cross contamination 
between positive and negative parts and carcasses during further processing.
77 78 
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.
81Additionally, 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.
82In 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 
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83FSIS Guidance for Controlling Salmonella in 
Poultry (June 2021) pp. 59. Available at: https://
www.fsis.usda.gov/guidelines/2021-0005. 
84Codex 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. 85The 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. 86FSIS Outbreak Reports at: https://
www.fsis.usda.gov/food-safety/foodborne-illness- and-disease/outbreaks. 
87Centers for Disease Control and Prevention: 
National Outbreak Reporting System at: https://wwwn.cdc.gov/norsdashboard/. 
88Brenner 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. 
89Shu-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 
90Scallan, 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. for further processing.83 84Salmonella- 
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. 
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)).
85Moreover, 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. 
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.
86Serotypes 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,
88though 
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,
89though 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. 
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 
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91NACMCF (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. 
92USDA 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. 
93FSIS 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%20survi%20...%20%209%20more%20rows%20?msclkid=f7030eaea6c411ec9e91f63d1dde98ff. 
94USDA 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=261bd671a6c411eca6c1c87daaae90cd. 95Killalea, 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. 
96Kasuga 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. 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.
91The 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. 
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.
92As 
part of this initiative, FSIS will leverage USDA’s strong research
93capabilities 
and strengthen its partnership with the USDA Research Education and Economics
94mission 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. 
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.
95Additionally, 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.
96Thus, 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 
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97Teunis P.F., et al., Dose-response modeling of 
Salmonella using outbreak data. Int J Food 
Microbiol, 2010. 144(2): p. 243–9. 
98World Health Organization, Risk assessment of 
Salmonella in eggs and broiler chickens, March 25, 2002. Available at: https://www.who.int/ publications/i/item/9291562293. 
99Based on product formulation information. 100Batz, 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. 
101Mughini-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. 
102Scallan, et al., 2011. 103Scallan, 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. 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 × 10
7 
CFU).97The 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.
98Also 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. 
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;
99and (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. 
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.
101And can cause 
debilitating, long-lasting conditions including inflammatory bowel disease, irritable bowel syndrome and reactive arthritis. 
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.
102The 
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. 
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 
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 
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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 °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 
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104This 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. 
105FSIS Microbiology Laboratory Guidebook 
available at: https://www.fsis.usda.gov/news-events/ publications/microbiology-laboratory-guidebook. 106For example, on July 8, 2022, FSIS announced 
that it had awarded a contract to bioMe ´rieux to 
incorporate its non-enrichment quantification system for Salmonella, ‘GENE–UP
TMQUANT 
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%20step%20in%20FSIS%E2%80%99,regulatory%20sample%2C%20not%20solely%20its%20presence%20or%20absence. 
107FSIS Outbreak Reports at: https://
www.fsis.usda.gov/food-safety/foodborne-illness- and-disease/outbreaks. 
108Centers for Disease Control and Prevention: 
National Outbreak Reporting System at: https://wwwn.cdc.gov/norsdashboard/. 
109USDA 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. 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 
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.
105When 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. 
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 
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  
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.
109These 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 
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110FSIS Compliance Guideline: Controlling Meat 
and Poultry Product Pending FSIS Test Results 
(2013) at: https://www.fsis.usda.gov/guidelines/ 2013-0003. 111FSIS is not aware of any State-inspected 
establishments that produce NRTE stuffed chicken products. clearly appears raw and is not typically 
cooked from a frozen state. 
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.
110In 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. 
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.
111Any 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 
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112FSIS used its Public Health Information 
System (PHIS) data accessed on 07/28/2022. 113Numbers may not calculate due to rounding. 
114Numbers rounded to the nearest month. 
115Scallan, 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. 
116Under 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. 
117Grants and Financial Options, USDA FSIS 
https://www.fsis.usda.gov/inspection/apply-grant- 
inspection/grants-financial-options. 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. 
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.
112These 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. 
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).
113Although 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.
114Between 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 
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.
116FSIS 
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. 
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 
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: program.intake@usda.gov. 
USDA is an equal opportunity 
provider, employer, and lender. 
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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, unspecified ...................... Enteri tidis. 
2 ................... CDC NORS ................ 1998 Chicken ....................... chicken ......................................... . Enteritidis. 
3 ................... CDC NORS ................ 1998 Chicken ....................... chicken ......................................... . Enteritidis. 
4 ................... CDC NORS ................ 1998 Chicken ....................... chicken, unspecified ...................... Group E1. 
5 ................... CDC NORS ................ 1998 Chicken ....................... chicken, unspecified ...................... Typhim urium. 
6 ................... PubMed ...................... 1998 Chicken ....................... chicken Kiev ................................ .. Typhimurium. 
7 ................... CDC NORS ................ 1999 Chicken ....................... chicken salad ................................. En teritidis. 
8 ................... CDC NORS ................ 1999 Chicken ....................... chicken, unspecified ...................... Enteri tidis. 
9 ................... CDC NORS ................ 1999 Chicken ....................... chicken, unspecified; mung bean 
sprouts.Enteritidis. 
10 ................. CDC NORS ................ 1999 Chicken ....................... chicken, unspecified ...................... Give. 
11 ................. CDC NORS ................ 1999 Chicken ....................... chicken, baked .............................. Hadar . 
12 ................. CDC NORS ................ 1999 Chicken ....................... chicken, unspecified ...................... Hadar. 
13 ................. CDC NORS ................ 1999 Chicken ....................... chicken, bbq .................................. Hei delberg. 
14 ................. CDC NORS ................ 1999 Chicken ....................... chicken, unspecified ...................... Javiana . 
15 ................. CDC NORS ................ 1999 Chicken ....................... chicken, other ................................ Mue nchen. 
16 ................. CDC NORS ................ 1999 Chicken ....................... burrito, chicken; taco, chicken; 
chicken, nuggets/fingers.Typhimurium. 
17 ................. CDC NORS ................ 1999 Chicken ....................... deli meat, sliced chicken ............... Unsubtype d. 
18 ................. CDC NORS ................ 1999 Chicken ....................... chicken, unspecified ...................... Unsubty ped. 
19 ................. CDC NORS ................ 2000 Chicken ....................... chicken, unspecified ...................... Group B . 
20 ................. CDC NORS ................ 2000 Chicken ....................... chicken, bbq .................................. Group C1. 
21 ................. CDC NORS ................ 2000 Chicken ....................... chicken, fried ................................. Ne wport. 
22 ................. CDC NORS ................ 2000 Chicken ....................... chicken, unspecified ...................... Newport . 
23 ................. CDC NORS ................ 2000 Chicken ....................... chicken, unspecified ...................... Typhimu rium. 
24 ................. CDC NORS ................ 2001 Chicken ....................... chicken, grilled ............................... Br aenderup. 
25 ................. CDC NORS ................ 2001 Chicken ....................... chicken, nuggets/fingers ................ Enteritid is. 
26 ................. CDC NORS ................ 2001 Chicken ....................... chicken, baked .............................. Enter itidis. 
27 ................. CDC NORS ................ 2001 Chicken ....................... chicken, fried ................................. Ne wport. 
28 ................. CDC NORS ................ 2001 Chicken ....................... specialty salads unspecified .......... Typhimurium . 
29 ................. CDC NORS ................ 2001 Chicken ....................... chicken, other ................................ Typ himurium. 
30 ................. CDC NORS ................ 2001 Chicken ....................... chicken, other ................................ Uns ubtyped. 
31 ................. CDC NORS ................ 2001 Chicken ....................... chicken, other ................................ Uns ubtyped. 
32 ................. CDC NORS ................ 2002 Chicken ....................... chicken .......................................... Enteritidis. 
33 ................. CDC NORS ................ 2002 Chicken ....................... chicken, other ................................ Rub islaw. 
34 ................. CDC NORS ................ 2002 Chicken ....................... chicken, baked .............................. Unsub typed. 
35 ................. CDC NORS ................ 2003 Chicken ....................... sauces, unspecified; chicken, un-
specified.Enteritidis. 
36 ................. CDC NORS ................ 2003 Chicken ....................... chicken, baked .............................. Enter itidis. 
37 ................. CDC NORS ................ 2003 Chicken ....................... chicken, baked .............................. Newport; Muenster; 
Heidelberg. 
38 ................. CDC NORS ................ 2003 Chicken ....................... chicken, unspecified ...................... Typhimu rium. 
39 ................. CDC NORS ................ 2003 Chicken ....................... chicken, other ................................ Uns ubtyped. 
40 ................. CDC NORS ................ 2003 Chicken ....................... chicken, roasted ............................ Unsub typed. 
41 ................. CDC NORS ................ 2004 Chicken ....................... chicken, raw .................................. Ent eritidis. 
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 ................................ Hei delberg. 
46 ................. CDC NORS ................ 2004 Chicken ....................... chicken, unspecified ...................... Heidelb erg. 
47 ................. CDC NORS ................ 2004 Chicken ....................... chicken, unspecified ...................... Heidelb erg. 
48 ................. CDC NORS ................ 2004 Chicken ....................... chicken, other ................................ Tho mpson. 
49 ................. CDC NORS ................ 2004 Chicken ....................... chicken, baked .............................. Typhi murium. 
50 ................. CDC NORS ................ 2004 Chicken ....................... chicken, other ................................ Typ himurium. 
51 ................. CDC NORS ................ 2004 Chicken ....................... chicken, grilled ............................... Typhimurium var 
Cope. 
52 ................. CDC NORS ................ 2004 Chicken ....................... chicken, unspecified ...................... Unsubty ped. 
53 ................. CDC NORS ................ 2005 Chicken ....................... chicken, grilled ............................... En teritidis. 
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Running total Data source Year Poultry type Product Subtype 
54 ................. CDC NORS ................ 2005 Chicken ....................... stuffing/dressing; gravy, chicken; 
chicken, other.Enteritidis. 
55 ................. CDC NORS ................ 2005 Chicken ....................... chicken, grilled ............................... En teritidis. 
56 ................. CDC NORS ................ 2005 Chicken ....................... stuffed chicken .............................. Ente ritidis; 
Typhimurium; Ken-
tucky. 
57 ................. CDC NORS ................ 2005 Chicken ....................... chicken, other ................................ Hei delberg. 
58 ................. CDC NORS ................ 2005 Chicken ....................... stuffed chicken (Chicken Broccoli 
and Cheese).Heidelberg. 
59 ................. CDC NORS ................ 2005 Chicken ....................... chicken, other ................................ Uns ubtyped. 
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, unspecified ...................... Newport . 
63 ................. CDC NORS ................ 2006 Chicken ....................... chicken, teriyaki; sushi, unspec-
ified.Typhimurium. 
64 ................. PubMed ...................... 2006 Chicken ....................... Chicken Kiev, Chicken Broccoli 
and Cheese, Chicken Mush-rooms and Cheddar, Chicken Mushrooms in Wine Sauce, and/or Chicken Romanov.Typhimurium. 
65 ................. CDC NORS ................ 2006 Chicken ....................... chicken, unspecified ...................... Typhimurium var 
Cope. 
66 ................. CDC NORS ................ 2007 Chicken ....................... chicken, bbq .................................. Bra enderup. 
67 ................. CDC NORS ................ 2007 Chicken ....................... chicken dishes, unspecified .......... Enteritidis.  
68 ................. CDC NORS ................ 2007 Chicken ....................... ribs, bbq; chicken wings, bbq ........ Enteritidis.  
69 ................. CDC NORS ................ 2007 Chicken ....................... Not RTE frozen chicken pot pie .... I 4,[5],12:i:-.  
70 ................. CDC NORS ................ 2007 Chicken ....................... chicken .......................................... Schwarzengrund. 
71 ................. CDC NORS ................ 2007 Chicken ....................... chicken, baked; chicken, grilled .... Typhimurium. 
72 ................. CDC NORS ................ 2008 Chicken ....................... specialty/ethnic dishes .................. Enteriti dis. 
73 ................. CDC NORS ................ 2008 Chicken ....................... chicken, roasted ............................ Typhi murium. 
74 ................. CDC NORS ................ 2008 Chicken ....................... chicken, other ................................ Typ himurium. 
75 ................. CDC NORS ................ 2008 Chicken ....................... chicken, unspecified ...................... Typhimu rium. 
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 and Rice frozen 
meals (frozen entre ´e).Chester. 
81 ................. CDC NORS ................ 2010 Chicken ....................... chicken and rice ............................ Enter itidis. 
82 ................. CDC NORS ................ 2010 Chicken ....................... chicken salad ................................. Ent eritidis. 
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 ................................ Ent eritidis. 
87 ................. CDC NORS ................ 2011 Chicken ....................... chicken .......................................... Enteritidis. 
88 ................. CDC NORS ................ 2011 Chicken ....................... Kosher Broiled Chicken Livers ...... Heidelberg. 
89 ................. CDC NORS ................ 2011 Chicken ....................... chicken, other ................................ Mon tevideo. 
90 ................. CDC NORS ................ 2011 Chicken ....................... chicken .......................................... Typhimurium var 
Cope. 
91 ................. CDC NORS ................ 2012 Chicken ....................... chicken .......................................... Enteritidis. 
92 ................. CDC NORS ................ 2012 Chicken ....................... fajita, chicken ................................. E nteritidis. 
93 ................. CDC NORS ................ 2012 Chicken ....................... chicken .......................................... Heidelberg. 
94 ................. CDC NORS ................ 2012 Chicken ....................... chicken, baked .............................. Javia na. 
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 .............................. Ent eritidis. 
99 ................. CDC NORS ................ 2013 Chicken ....................... chicken .......................................... Enteritidis. 
100 ............... CDC NORS ................ 2013 Chicken ....................... ground chicken .............................. Enteri tidis. 
101 ............... CDC SNORS .............. 2013 Chicken ....................... Mechanically Separated Chicken .. Heidelberg. 
102 ............... CDC NORS ................ 2013 Chicken ....................... chicken .......................................... H eidelberg. 
103 ............... CDC NORS ................ 2013 Chicken ....................... chicken mole ................................. Heide lberg. 
104 ............... CDC SNORS .............. 2013 Chicken ....................... chicken products ........................... Heidelbe rg. 
105 ............... CDC NORS ................ 2013 Chicken ....................... chicken .......................................... J aviana. 
106 ............... CDC NORS ................ 2013 Chicken ....................... chicken, bbq .................................. Mont evideo. 
107 ............... CDC NORS ................ 2014 Chicken ....................... chicken .......................................... C armel. 
108 ............... CDC NORS ................ 2014 Chicken ....................... chicken .......................................... E nteritidis. 
109 ............... CDC NORS ................ 2014 Chicken ....................... chicken .......................................... E nteritidis. 
110 ............... CDC NORS ................ 2014 Chicken ....................... chicken, casserole ......................... Enterit idis. 
111 ............... FSIS/NORS ................ 2014 Chicken ....................... stuffed chicken (chicken kiev) ....... Enteritidis.  
112 ............... CDC NORS ................ 2014 Chicken ....................... chicken liver pate .......................... Enteri tidis. 
113 ............... CDC NORS ................ 2014 Chicken ....................... chicken .......................................... Enteritidis; Enteritidis. 
114 ............... CDC NORS ................ 2014 Chicken ....................... chicken, smoked ............................ Heidelb erg. 
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Running total Data source Year Poultry type Product Subtype 
115 ............... CDC NORS ................ 2014 Chicken ....................... chicken, grilled ............................... Hei delberg. 
116 ............... CDC NORS ................ 2014 Chicken ....................... chicken .......................................... I nfantis. 
117 ............... CDC NORS ................ 2014 Chicken ....................... chicken, smoked ............................ Thompso n. 
118 ............... CDC NORS ................ 2014 Chicken ....................... sandwich, chicken ......................... Thompson . 
119 ............... CDC NORS ................ 2015 Chicken ....................... chicken, rotisserie .......................... Braen derup. 
120 ............... CDC NORS ................ 2015 Chicken ....................... chicken, rotisserie .......................... Derby . 
121 ............... CDC NORS ................ 2015 Chicken ....................... Stuffed chicken .............................. Enter itidis. 
122 ............... CDC NORS ................ 2015 Chicken ....................... chicken tenders ............................. Enteri tidis. 
123 ............... FSIS/NORS ................ 2015 Chicken ....................... frozen, raw, stuffed and breaded 
chicken.Enteritidis. 
124 ............... FSIS/NORS ................ 2015 Chicken ....................... chicken Kiev, cordon bleu, ............ Enteritidis . 
125 ............... CDC NORS ................ 2015 Chicken ....................... chicken, grilled; chicken, black-
ened.Enteritidis. 
126 ............... CDC NORS ................ 2015 Chicken ....................... chicken and waffles ....................... Enteriti dis. 
127 ............... CDC NORS ................ 2015 Chicken ....................... chicken katsu plate; korean chick-
en.Muenchen. 
128 ............... CDC NORS ................ 2015 Chicken ....................... chicken, roasted ............................ Unsubt yped. 
129 ............... FSIS/NORS ................ 2016 Chicken ....................... Stuffed chicken .............................. Ente ritidis. 
130 ............... CDC NORS ................ 2016 Chicken ....................... pate, chicken liver ......................... Enteri tidis. 
131 ............... CDC NORS ................ 2016 Chicken ....................... chicken, baked .............................. Enteritidis; Enteritidis; 
Enteritidis. 
132 ............... CDC NORS ................ 2016 Chicken ....................... chicken .......................................... H eidelberg. 
133 ............... CDC NORS ................ 2016 Chicken ....................... rotisserie chicken salad from 
Costco’s Alderwood store.I 4,[5],12:i:-. 
134 ............... CDC NORS ................ 2016 Chicken ....................... chicken .......................................... M uenchen. 
135 ............... CDC NORS ................ 2016 Chicken ....................... chicken .......................................... N orwich. 
136 ............... CDC NORS ................ 2016 Chicken ....................... chicken .......................................... S aintpaul. 
137 ............... CDC NORS ................ 2016 Chicken ....................... chicken .......................................... T hompson. 
138 ............... CDC NORS ................ 2016 Chicken ....................... chicken .......................................... U nsubtyped. 
139 ............... CDC NORS ................ 2017 Chicken ....................... sandwich, chicken ......................... Anatum. 
140 ............... CDC NORS ................ 2017 Chicken ....................... chicken .......................................... E nteritidis. 
141 ............... CDC NORS ................ 2017 Chicken ....................... chicken .......................................... E nteritidis. 
142 ............... CDC NORS ................ 2017 Chicken ....................... chicken dishes ............................... Enter itidis. 
143 ............... CDC NORS ................ 2017 Chicken ....................... kabobs, chicken ............................. Enteri tidis. 
144 ............... CDC NORS ................ 2017 Chicken ....................... chicken salad sandwich; grilled 
chicken salad; chicken caesar 
salad.Enteritidis. 
145 ............... CDC NORS ................ 2017 Chicken ....................... chicken .......................................... E nteritidis. 
146 ............... CDC NORS ................ 2017 Chicken ....................... chicken .......................................... E nteritidis. 
147 ............... CDC NORS ................ 2017 Chicken ....................... chicken, pulled ............................... Heid elberg. 
148 ............... CDC NORS ................ 2017 Chicken ....................... chicken .......................................... I 4,[5],12:i:-. 
149 ............... CDC NORS ................ 2017 Chicken ....................... chicken, smoked ............................ Infanti s. 
150 ............... CDC NORS ................ 2018 Chicken ....................... chicken, raw .................................. Bloc kley. 
151 ............... CDC NORS ................ 2018 Chicken ....................... chicken .......................................... B lockley. 
152 ............... CDC NORS ................ 2018 Chicken ....................... chicken, grilled ............................... Bra enderup. 
153 ............... CDC NORS ................ 2018 Chicken ....................... chicken .......................................... E nteritidis. 
154 ............... FSIS/NORS ................ 2018 Chicken ....................... raw breaded chicken ..................... Enteritid is. 
155 ............... CDC NORS ................ 2018 Chicken ....................... chicken, smoked ............................ Enterit idis. 
156 ............... CDC NORS ................ 2018 Chicken ....................... smoked chicken ............................. Enterit idis. 
157 ............... CDC NORS ................ 2018 Chicken ....................... chicken, other ................................ Ente ritidis. 
158 ............... CDC NORS ................ 2018 Chicken ....................... chicken .......................................... Enteritidis; Thompson. 
159 ............... CDC NORS ................ 2018 Chicken ....................... chicken, raw .................................. Heid elberg. 
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 ................................ Typhi murium. 
163 ............... CDC NORS ................ 2018 Chicken ....................... chicken .......................................... T yphimurium. 
164 ............... CDC NORS ................ 2019 Chicken ....................... chicken .......................................... B raenderup. 
165 ............... CDC NORS ................ 2019 Chicken ....................... chicken .......................................... E nteritidis. 
166 ............... CDC NORS ................ 2019 Chicken ....................... chicken .......................................... E nteritidis. 
167 ............... CDC NORS ................ 2019 Chicken ....................... chicken .......................................... E nteritidis. 
168 ............... CDC NORS ................ 2019 Chicken ....................... chicken fingers .............................. Enter itidis. 
169 ............... CDC NORS ................ 2019 Chicken ....................... chicken .......................................... E nteritidis. 
170 ............... CDC NORS ................ 2019 Chicken ....................... chicken .......................................... E nteritidis. 
171 ............... CDC NORS ................ 2019 Chicken ....................... mechanically separated chicken ... Enteritidis; Infa ntis. 
172 ............... CDC NORS ................ 2019 Chicken ....................... chicken .......................................... H eidelberg. 
173 ............... CDCNORS .................. 2019 Chicken ....................... chicken products ........................... Infant is. 
174 ............... CDC NORS ................ 2019 Chicken ....................... chicken .......................................... I nfantis. 
175 ............... CDC NORS ................ 2019 Chicken ....................... chicken .......................................... T hompson. 
176 ............... CDC NORS ................ 2020 Chicken ....................... chicken .......................................... E nteritidis. 
177 ............... CDC NORS ................ 2020 Chicken ....................... chicken .......................................... E nteritidis. 
178 ............... CDC NORS ................ 2020 Chicken ....................... chicken .......................................... E nteritidis. 
VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1ddrumheller on DSK120RN23PROD with NOTICES126271 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices 
[FR Doc. 2023–09043 Filed 4–27–23; 8:45 am] 
BILLING CODE 3410–DM–P 
DEPARTMENT OF AGRICULTURE 
Food and Nutrition Service Agency Information Collection 
Activities: Child and Adult Care Food Program (CACFP) National Disqualified List 
AGENCY : Food and Nutrition Service 
(FNS), USDA. 
ACTION : Notice. 
SUMMARY : In accordance with the 
Paperwork Reduction Act of 1995, this notice invites the general public and 
other public agencies to comment on this proposed information collection. This collection is an extension, without change, of a currently approved collection for maintaining the National Disqualified List of institutions, day care home providers, and individuals that have been terminated or otherwise disqualified from Child and Adult Care Food Program (CACFP) participation. These federal requirements affect eligibility under the CACFP. The State Agencies are required to enter data as institutions and individuals become disqualified from participating in the CACFP. 
DATES : Written comments must be 
received on or before June 27, 2023. 
ADDRESSES : Comments may be sent to: 
Jessica Saracino, Director, Program Monitoring and Operational Support Branch, Child Nutrition Division, Food and Nutrition Service, U.S. Department of Agriculture, 1320 Braddock Place, Alexandria, VA, 22314. Comments will also be accepted through the Federal eRulemaking Portal. Go to http://www.regulations.gov, and follow the 
online instructions for submitting comments electronically. 
All responses to this notice will be 
summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record. 
FOR FURTHER INFORMATION CONTACT : 
Requests for additional information or copies of this information collection should be directed to Suzanne Diggs at (703) 305–3223. 
SUPPLEMENTARY INFORMATION : 
Comments are invited on: (a) Whether 
the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. 
Title: Child and Adult Care Food 
Program (CACFP) National Disqualified List. 
Form Number: FNS–843 and FNS– 
844. 
OMB Number: 0584–0584. 
Expiration Date: July 31, 2023. Type of Request: Extension, without 
change, of a currently approved 
collection. 
Abstract: The Food and Nutrition 
Service administers the Child Nutrition Act of 1966, as amended (42 U.S.C. 1771, et seq.). Section 243(c) of Public 
Law 106–224, the Agricultural Risk Protection Act of 2000, amended section 17(d)(5) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1766 (d)(5)(E)(i) and (ii)) by requiring the Department of Agriculture to maintain a list of institutions, day care home providers, and individuals that have been terminated or otherwise disqualified from Child and Adult Care Food Program participation. The law also requires the Department to make the list available to State agencies for their use in reviewing applications to participate in the program and to sponsoring organizations to ensure that they do not employ as principals any persons who are disqualified from the program. Forms FNS–843 Report of Disqualification from Participation— Institutions and Responsible Principals/ Individuals and FNS–844 Report of Disqualification from Participation— Individually Disqualified Responsible Principal/Individual or Day Care Home Provider are used to collect and maintain this data via a FNS web-based system constructed to update and maintain the list of disqualified institutions and individuals so that no State agency or sponsoring organization may approve any entity on the National Disqualified List to ensure the integrity of the Program. This statutory mandate has been incorporated into § 226.6(c)(7) of the Program regulations. In addition, the recordkeeping burden associated with maintaining documentation related to institutions and providers terminated for cause at the State agency level is captured under the Information Collection for the CACFP, OMB Control Number 0584–0055 Child and Adult Care Food Program (CACFP), expiration date August 31, 2025. Therefore, there is no recordkeeping burden associated with this collection. 
Affected Public: State, Local, and 
Tribal Government. State Agencies are the respondents. 
Estimated Number of Respondents: 
56. 
Estimated Number of Responses per 
Respondent: 28. 
Estimated Total Annual Responses: 
1,568. 
Estimate Time per Response: 0.50. 
Estimated Total Annual Burden: 784. 
Affected public Instrument Estimated 
number of 
respondents Number of 
responses per 
respondent Total 
annual 
responses Estimated 
total hours 
per response Estimated 
total 
burden 
Reporting 
State Agencies ........................................ FNS 843 ........ 56 6 336 .50 168 
State Agencies ........................................ FNS 844 ........ 56 22 1,232 .50 616 
Total Estimated Reporting Burden ... ........................ 56 28 1,568 0.50 784 
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