Salmonella in Not-Ready-To-Eat Breaded Stuffed Chicken Products, 26249-26271 [2023-09043]

Download as PDF 26249 Notices Federal Register Vol. 88, No. 82 Friday, April 28, 2023 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2022–0013] Salmonella in Not-Ready-To-Eat Breaded Stuffed Chicken Products Food Safety and Inspection Service, USDA. ACTION: Proposed determination and request for comments. AGENCY: 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 adulteration of breaded stuffed NRTE products. 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: ADDRESSES: Table of Contents I. Background Pathogens as Adulterants in Raw and NotReady-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 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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 E:\FR\FM\28APN1.SGM 28APN1 26250 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices products based on the assumption that ordinary cooking is generally sufficient to destroy the pathogens.1 2 The exceptions are Escherichia coli O157:H7 (E. coli O157:H:7) 3 and certain nonO157 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 ddrumheller on DSK120RN23PROD with NOTICES1 STEC as Adulterants When FSIS determined that certain STEC are adulterants in non-intact raw beef products, the Agency identified characteristics associated with both the pathogen and the product that distinguish them from other raw products contaminated with other pathogens. Specifically, in 1994, when FSIS initially notified the public that raw ground beef products contaminated with E. coli O157:H7 are adulterated within the meaning of the FMIA, the Agency noted that exposure to E. coli O157:H7 organisms had been linked with serious, life-threatening human illnesses, such as hemorrhagic colitis and hemolytic uremic syndrome (HUS).5 In addition, FSIS noted that 1 See proposed rule ‘‘Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems,’’ February 4, 1993 (60 FR 6774 at 6798– 6799) and final rule ‘‘Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems,’’ July 25, 1996 (61 FR 38806 at 38835.) See also Amer. Public Health Ass’n v. Butz, 511 F.2d 331 (U.S. App. DC, 1974). 2 When raw meat or poultry products are associated with an illness outbreak and contain pathogens that are not considered adulterants in those products, FSIS considers the product linked to the illness outbreak to be adulterated under 21 U.S.C. 601(m)(3) or 453(g)(3) because the product is ‘‘. . . unsound, unhealthful, unwholesome, or otherwise unfit for human food’’ (77 FR 72681, 72689 (Dec. 6, 2012). Products that contain an adulterant are considered adulterated under 21 U.S.C. 601(m)(1) or 453(g)(1) even if they are not linked to an illness outbreak. 3 On April 16, 2021, FSIS announced that it was aligning the testing criteria for E. coli O157:H7 with that for non-O157 STEC. Under the updated method, consistent with laboratory testing for nonO157 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/constituentupdate-april-16-2021). 4 See Texas Food Industry Association v. Espy, 870 F. Supp. 143 (1994). 5 Michael R. Taylor, FSIS Administrator. September 29, 1994. ‘‘Change and Opportunity to VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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 nonintact 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 nonintact raw products before being distributed for consumption. Improve the Safety of the Food Supply.’’ Speech to American Meat Institute Annual Convention, San Francisco, CA. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 In September 2011, FSIS determined that six additional STEC serogroups (O26, O45, O103, O111, O121, and O145) are also adulterants of raw nonintact 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, nonintact beef products that are contaminated with these pathogens are unhealthful and unwholesome (21 U.S.C. 601(m)(3)) (76 FR 31975). Petitions To Declare Certain Salmonella Serotypes as Adulterants As noted above, FSIS historically has not considered raw meat and poultry products to be adulterated when they contain Salmonella, based on the assumption that ordinary methods of cooking and preparing these products kill Salmonella. In response to petitions submitted by the Center for Science in the Public Interest (CSPI) in 2011 and 2014, FSIS evaluated whether certain antibiotic-resistant (ABR) Salmonella serotypes could be considered as adulterants in raw meat and raw poultry products under the FMIA and PPIA. The 2011 petition asked FSIS to declare four strains of ABR Salmonella as adulterants when found in ground meats and poultry.6 FSIS denied the 6 CSPI petition #11–06 (May 25, 2011), ‘‘Petition for an Interpretive Rule Declaring Specific Strains of Antibiotic Resistant Salmonella to be Adulterants Withing the Meaning or 21 U.S.C. 601(m)(1) and E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 2011 petition without prejudice on July 31, 2014. In its response, FSIS explained that the data available at that time ‘‘did not support giving the four strains of ABR Salmonella identified in the petition a different status as an adulterant in raw ground beef and raw ground poultry than Salmonella strains that are susceptible to antibiotics.’’ 7 The response stated that additional data on the characteristics of ABR Salmonella are needed to determine whether certain strains could qualify as adulterants under the FMIA and PPIA. The response also noted that because the Agency’s denial was without prejudice, the petitioner was not precluded from submitting a revised petition that includes additional information to support the requested action. The CSPI 2014 petition was a refiling of the 2011 petition and asked that FSIS declare certain strains of ABR Salmonella as adulterants in all meat and poultry products based on evidence attained since 2011 that, according to the petition, demonstrates both ground and intact poultry products are associated with outbreaks from ABR Salmonella.8 Based on the data available at the time, FSIS denied the 2014 petition without prejudice on February 7, 2018. In its response to the petition, the Agency concluded that, with respect to its status as an adulterant, ‘‘Salmonella does not appear to present the same issues as STEC, regardless of whether it is resistant or susceptible to antibiotics.’’ 9 The Agency noted that the consumer studies submitted in support of the petitions did not demonstrate that the study participants had expressed a specific preference or intent to prepare or consume a meat or poultry product in a manner that is not properly cooked and did not describe specific characteristics of a meat or poultry product that consumers might mistakenly associate with proper cooking, such as a rare or medium rare hamburger. Thus, based on the consumer studies and other information on Salmonella available at that time, FSIS determined that it ‘‘had no basis to conclude that either ABR-Salmonella or (2)(a) and 21 U.S.C. 453(g)(1) and (2)(a).’’ FSIS final response July 31, 2014. 7 FSIS final response to petition #11–06, p. 1. 8 CSPI petition #14–01 (October 1, 2014), ‘‘Request for an Interpretive Rule Declaring Certain Antibiotic-Resistant Strains of Salmonella to be Adulterants’’ and FSIS final response (February 7, 2018) at: https://www.fsis.usda.gov/federal-register/ petitions/request-interpretive-rule-declaringcertain-antibiotic-resistant-strains. 9 FSIS final response to petition #14–06, p. 6. Available at: https://www.fsis.usda.gov/federalregister/petitions/request-interpretive-ruledeclaring-certain-antibiotic-resistant-strains. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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 2020.11 The petition asked FSIS to declare 31 Salmonella serotypes that have been associated with foodborne illness outbreaks to be adulterants of all meat and poultry products subject to the FMIA and the PPIA. In its response to the petition, FSIS explained that while the Agency agrees that it needs to rethink its existing Salmonella strategy to reduce human illnesses associated with poultry, it does not believe that there is sufficient data available at this time to support the sweeping actions requested in the petition.12 The response noted that, as announced in October 2021,13 FSIS is in the process of re-evaluating its approach to controlling Salmonella in poultry and is considering many of the points and arguments made in the petition as part of its re-evaluation. The response also noted that while FSIS has traditionally viewed Salmonella as ‘‘naturally occurring’’ in food animals, the Agency is reassessing this interpretation as part of its Salmonella in poultry initiative and considering whether Salmonella should be considered an adulterant in any poultry products. The response stated that in this consideration, FSIS is relying on the factors it identified when the Agency declared certain STEC strains to be adulterants in raw nonintact beef products and intact source materials for raw ground beef. 10 FSIS final response to petition #14–06, p. 7. Available at: https://www.fsis.usda.gov/federalregister/petitions/request-interpretive-ruledeclaring-certain-antibiotic-resistant-strains. 11 Marler Clark LLP petition #20–01 ‘‘Petition for an Interpretive Rule Declaring ‘Outbreak’ Serotypes of Salmonella enteritica subspecies to be Adulterants’’ dated January 19, 2020. Available at: https://www.fsis.usda.gov/policy/petitions/petitioninterpretive-rule-related-certain-salmonellaserotypes. 12 FSIS Final Response to Petition #20–01, May 31, 2022. Available at: https://www.fsis.usda.gov/ policy/petitions/petition-interpretive-rule-relatedcertain-salmonella-serotypes. 13 United States Department of Agriculture. (October 19, 2021). USDA Launches New Effort to Reduce Salmonella Illness Linked to Poultry. https://www.usda.gov/media/press-releases/2021/ 10/19/usda-launches-new-effort-reduce-salmonellaillnesses-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-salmonellapoultry/pilot. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 26251 On January 25, 2021, CSPI and other consumer advocacy organizations and individuals petitioned FSIS to establish enforceable standards targeting Salmonella types of greatest public health concern and all Campylobacter in poultry, and to require supply chain controls.14 With respect to the request to establish enforceable performance standard, the petition asserts that FSIS should focus specifically on the types of Salmonella of greatest public health concern and declare the most virulent Salmonella strains to be adulterants in raw poultry products. The petition also requests that FSIS employ enforceable quantitative thresholds to ensure that any Salmonella or Campylobacter that is permitted on poultry products is maintained at levels low enough to be less likely to cause human illness. The petition asserts that 21 U.S.C. 453(g)(1) authorizes FSIS to deem poultry products that contain virulent Salmonella strains and that contain pathogens levels above a set threshold to be adulterated under the PPIA. 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, nonintact 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 14 CSPI petition #21–01, ‘‘Petition to Establish Enforceable Standards Targeting Salmonella Types of Greatest Public Health Concern while Reducing all Salmonella and Campylobacter in Poultry, and to Require Supply Chain Controls’’ (January 25, 2021) at: https://www.fsis.usda.gov/policy/ petitions/petition-submitted-center-science-publicinterest. E:\FR\FM\28APN1.SGM 28APN1 26252 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 products or about the specific preparation methods between non-intact raw beef and other raw products. The intent is to identify the criteria that were used to determine that certain STECs are adulterants in non-intact beef and apply these criteria to assess whether there are other pathogens that should be considered as adulterants when present in a specific raw product. Specifically, the Agency would consider whether certain pathogen serogroups or types have been associated with human illnesses; whether the pathogen has a relatively low infectious dose; whether the pathogen can cause serious human illnesses; and whether traditional or ordinary cooking practices associated with the specific raw products are sufficient to destroy the pathogen. II. NRTE Breaded Stuffed Chicken Products NRTE breaded stuffed chicken products contain raw, comminuted chicken breast meat, trim, or whole chicken breast meat, but the finished product is heat-treated only to set the batter or breading on the exterior of the product, which may impart an RTE appearance.15 The product typically is stuffed with ingredients, such as a raw vegetable, butter, cheese or meat such as ham, and is typically cooked by household consumers from a frozen state. NRTE breaded stuffed chicken products do not include other types of stuffed products that are not breaded, such as turducken or whole stuffed chickens. NRTE breaded products that are not also stuffed, such as chicken nuggets and other par-fried products are not included in this product type. Only NRTE products that are both breaded and stuffed are the subject of this policy. 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 15 FSIS Directive 5300.1, Revision 1. Managing the Establishment Profile in the Public Health Information System (Oct 19, 2016). See attachment 2 ‘‘NRTE Stuffed Chicken Products that appear RTE.’’ Available at: https://www.fsis.usda.gov/ policy/fsis-directives/5300.1. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 focus of this document is on NRTE breaded stuffed chicken products because these stuffed products are thicker in diameter and have a different composition than other par-fried breaded products, which can make effective cooking of NRTE breaded stuffed chicken products more challenging. In addition, it may be difficult for a consumer to determine an accurate internal temperature of these products because they contain multiple ingredients that may cook at different rates. FSIS has recommended in the past that consumers check the temperature at multiple locations throughout the product, but this is not always practical or accurate.16 In addition, NRTE breaded stuffed chicken products have been associated with a number of Salmonella illness outbreaks in the United States. 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 16 Smith, K.E., Medus, C., Meyer, S.D., Boxrud, J.D., Leano, F., Hedburg, C., Elfering, K., Braymen, C., Bender, J.B., Danila, R.N. 2008. Outbreaks of Salmonellosis in Minnesota (1998 through 2006) Associated with Frozen, Microwaveable, Breaded Stuffed Chicken Products. Journal of Food Protection. 71(10): 2153–2160. PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 Agency identified in the CDC National Outbreak Reporting System (NORS) 17 or in the scientific literature from 1998– 2020 found that although NRTE breaded stuffed chicken products account for less than 0.15 percent of the total domestic chicken supply (in 2021, 53.9 million pounds of NRTE breaded stuffed chicken were produced compared to 45.4 billion pounds of raw chicken products overall), outbreaks linked to these products represented approximately five percent of all chicken-associated outbreaks in the United States during this time. (See Appendix A for the list of Salmonella outbreak investigations associated with all chicken products from 1998–2020). Salmonella Illness Outbreak Investigations Associated With NRTE Breaded Stuffed Chicken Products 1998–2016 and FSIS and Industry Response 1998–2006 outbreak investigations. From 1998 through 2006, four separate outbreaks of salmonellosis associated with consumption of NRTE breaded stuffed chicken products were identified in Minnesota.18 In the first outbreak in 1998, 33 Salmonella Typhimurium cases were associated with a single brand of raw, frozen, stuffed, breaded, pre-browned, and microwaveable Chicken Kiev product.19 Of the 33 people who became ill, 3 were hospitalized for a range of 2–3 days. The outbreak duration was 5 months. Most case patients reported that they thought the product was pre-cooked, and most prepared the product in a microwave oven. No case patients reported taking an internal temperature of the product after cooking. In response to the outbreak, the company that produced the product initiated a voluntary recall of the implicated products and made several changes to the product label, such as replacing the words ‘‘ready to cook’’ on the principal display panel with the words ‘‘not precooked’’ and adding ‘‘not pre-cooked—cook thoroughly’’ and ‘‘cook to an internal temperature of 165 °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 17 CDC National Outbreak Reporting System available at: https://www.cdc.gov/nors/. 18 Smith K, Medus C, Meyer S. et al. Outbreaks of Salmonellosis in Minnesota (1998 through 2006) Associated with frozen, microwavable, breaded, stuffed chicken products (2008). Journal of Food Protection, 71(10), 2153–2160. 19 Smith, K. et al. (2008). 20 Smith, K. et al. (2008). E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 One elderly case patient was hospitalized for 4 days. The duration of the outbreak was three months. A separate published report noted that additional Salmonella cases associated with similar products were also reported in Michigan.21 In response to the outbreak, FSIS issued a public health alert (PHA) to remind consumers that frozen meat and poultry products must be fully cooked before they are consumed. In addition, the manufacturer modified the labels of the products to include the word ‘‘uncooked’’ and verified the cooking instructions. In the third outbreak in August 2005 through July 2006, 27 Salmonella Enteritidis cases were associated with a variety of raw, frozen, stuffed, breaded, pre-browned, and microwaveable chicken products.22 The products represented eight product brands produced by three separate companies. Salmonella Enteritidis was isolated from intact samples of breaded stuffed chicken products produced in an establishment owned by one of the companies. Of the 27 case patients, 6 were hospitalized. The length of hospitalization ranged from 2 to 30 days. Two elderly case patients were hospitalized for 30 days. Another case patient required surgery for a perforated colon. The duration of the outbreak was 11 months. Nineteen of the 27 case patients used a microwave oven to cook the products and none of the case patients took the internal temperature of the product after cooking it. The establishment that produced the products from which Salmonella Enteritidis had been isolated voluntarily recalled 75,800 pounds of frozen, breaded stuffed NRTE chicken entrees.23 Because of the ongoing nature of this outbreak, FSIS issued a PHA in July 2006 to provide additional information to enable consumers to more readily identify the class of products implicated in the outbreak and to emphasize that they must be cooked to an internal temperature of 165 °F.24 The PHA noted that in addition to the 21 Response to the Questions Posed by the Food Safety and Inspection Service Regarding Consumer Guidelines for the Safe Cooking of Poultry Products; APPENDIX I. REPORT ON SALMONELLOSIS LINKED TO CONSUMING PROCESSED CHICKEN PRODUCTS IN MINNESOTA AND MICHIGAN: SUMMARY OF A PRESENTATION GIVEN TO NACMCF ON 7 JULY 2005 BY MR. KEVIN ELFERING OF THE MINNESOTA DEPARTMENT OF AGRICULTURE. Journal of Food Protection, 70(1), 251–260. 22 Smith, K. et al. (2008). 23 FSIS Recall Release: Indiana Firm Recalls Frozen Stuffed Chicken Entrees Associated with Illnesses (March 10, 2006). 24 FSIS Issues Public Health Alert for Frozen, Stuffed, Raw Chicken Products (July 2006). VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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.25 Two of the case patients were hospitalized for 2 days each. The duration of the outbreak was two months. All three case patients microwaved the product, and none used a thermometer to check the internal temperature of the product. 2005–2006 FSIS and industry response. In March 2006, in response to the 2005–2006 Salmonella Enteritidis outbreak and recall, FSIS sent a letter to all establishments that produced frozen NRTE breaded stuffed chicken products to strongly recommend that the labeling of these products be modified to emphasize that the products are not cooked. FSIS also recommended that these establishments enhance and validate the cooking instructions to ensure that they address the intended use by the consumer. FSIS posted the letter to the FSIS website.26 The letter explained that a statement on the principal display panel of the packaging, such as ‘‘Uncooked: For Safety, Must be Cooked to an Internal Temperature of 165 degrees F as Measured by Use of a Thermometer’’, would be appropriate to help consumers understand the need to safely prepare the product on their part. The letter also stated that in light of the concerns associated with the NRTE breaded stuffed chicken products subject to the recall, establishments were requested to submit their revised labeling to FSIS for evaluation of the necessary modifications and re-approval. The letter noted that if FSIS did not receive the modified labeling submissions by May 1, 2006, the labels for the subject products would be deemed to be rescinded. 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 25 Smith, K. et al. (2008). to industry about the safe handling labeling of uncooked, breaded, boneless poultry products (March 2006) at: https:// www.fsis.usda.gov/guidelines/2006-0007. 26 Letter PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 26253 breaded stuffed chicken products.27 The NACMCF recommended, among other things, that consumers should be advised to cook these products to a single minimum internal temperature of 165 °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.29 Specifically, FSIS IPP were instructed to verify that the establishments had new labeling along with adequate validation to support the cooking instructions to be included on the product label. 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 27 Response to the Questions Posed by the Food Safety and Inspection Service Regarding Consumer Guidelines for the Safe Cooking of Poultry Products. Journal of Food Protection, 70(1), 251–260. 28 Labeling Policy Guidance Uncooked, Breaded, Boneless Poultry Products (April 2006) at: https:// www.fsis.usda.gov/guidelines/2017-0001. 29 FSIS Notice 75–06, Verification Instructions for Changes in Label Requirements for Uncooked and Raw Frozen, Breaded, Boneless Poultry Products (Nov 13, 2006). Supplemental Q’s and A’s to Address Products Affected by FSIS Notice 75–06 Verification Instructions for Changes in Label Requirements for Uncooked and Raw Frozen, Breaded, Boneless Poultry Products at: https:// www.fsis.usda.gov/guidelines/2006-0008. E:\FR\FM\28APN1.SGM 28APN1 26254 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices outbreaks associated with NRTE breaded stuffed chicken products. From February to April 2008, the Minnesota Department of Health (MDH) identified seven Salmonella Enteritidis illnesses associated with frozen, pre-browned breaded stuffed chicken products.30 Five of the seven case patients reported cooking the product in the microwave, even though the cooking instructions did not include microwave preparation and recommended against that method of cooking. In response, FSIS issued a PHA in March 2008 to remind consumers of the importance of following package instructions for NRTE breaded stuffed chicken products and to emphasize that it is important to cook these products in a conventional oven.31 The PHA identified the establishment that had produced the products associated with the illnesses, and FSIS conducted a Food Safety Assessment (FSA) 32 at the establishment. In a separate investigation in October 2008, the MDH reported 14 Salmonella illness cases had been linked to raw, frozen, breaded, and pre-browned, stuffed Chicken Cordon Bleu and Chicken Kiev products.33 MDH reported that the outbreak strain of Salmonella was found in four packages of breaded stuffed chicken products recovered from the homes of some of the individuals that were ill and from grocery stores. The outbreak strain was identified as Salmonella I 4,[5],12:i:-.34 An investigation subsequently conducted by FSIS and other public health partners identified 47 illness cases from 17 States associated with the same outbreak strain with 8 reported hospitalizations.35 Information from case patients identified in Wisconsin found that 9 out of 11 reported that they consumed frozen NRTE breaded stuffed Chicken Kiev or Cordon Bleu products. Four of the Wisconsin case patients reported that they cooked the product in a microwave, and 4 reported that they cooked the product in an oven. After the investigation was initiated, FSIS issued a PHA due to concerns ddrumheller on DSK120RN23PROD with NOTICES1 30 Minnesota Department of Health Annual Summary of Disease Activity: Disease Control Newsletter. Salmonella 2008 at: https:// www.health.state.mn.us/diseases/reportable/dcn/ sum08/salmonellosis.html. 31 FSIS Public Health Alert, March 29, 2008. 32 The purpose of an FSA is to conduct a riskbased, 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). 33 MDH News Release; Salmonella cases linked to raw, frozen chicken entrees (Oct 8, 2008). 34 FSIS outbreak investigation case 2009–02. 35 FSIS outbreak investigation case 2009–02. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 about illnesses that may be associated with NRTE breaded stuffed chicken products.36 The PHA reminded consumers of the importance of following package cooking instructions for NRTE breaded stuffed chicken products and general food safety guidelines when handling raw meat or poultry products. 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.39 The illness onset dates were from April 2013 to July 2013. All three case patients reported consuming various NRTE chicken products produced by two separate establishments prior to illness onset. The Minnesota Department of Agriculture (MDA) collected and tested intact breaded stuffed chicken products from the case patients’ homes. Products produced by one of the establishments tested positive for Salmonella Enteritidis, Salmonella Typhimurium, Salmonella Kentucky, and Salmonella I 4,12:i:-. A Chicken Cordon Bleu and 36 FSIS Issues Public Health Alert, October 3, 2008. 37 FSIS outbreak investigation case 2009–23. 38 FSIS outbreak investigation case 2009–43. 39 FSIS outbreak investigation case 2013–17. PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 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 40 at establishments that produced NRTE breaded stuffed chicken products.41 The Notice stated that during the 2013 outbreak investigation, FSIS discovered that there are consumers that may be unaware that NRTE breaded stuffed chicken products can be produced as raw frozen products. The Notice explained that the frozen state, labeling, and cooked appearance of these products may cause consumers to falsely believe that such products are precooked. The Notice instructed IPP to verify that establishments producing NRTE breaded stuffed chicken products have appropriately considered the microbial hazards associated with these products and have documentation to support their resulting decisions. In a separate investigation in August 2014, six Salmonella Enteritidis illnesses in Minnesota were associated with NRTE breaded stuffed Chicken Kiev products.42 The illness onsets ranged from August 17, 2014, to September 27, 2014, and one case patient was hospitalized. In October 2014, the establishment that produced the product initiated a voluntary recall of 28,980 pounds of the product.43 The product labeling stated in several places that the product was raw and included validated cooking instructions as recommended in the FSIS guidance for labeling NRTE breaded stuffed chicken products. The FSIS recall release associated with the recall emphasized 40 An HAV task is a verification task performed by IPP focusing on establishments’ hazard analyses, pre-requisite programs, and other supporting documentation. 41 FSIS Notice 31–14, Supplemental Instructions for Performing the Hazard Analysis Verification Task in Establishments that Produce NRTE Stuffed Poultry Products (June 30, 2014). 42 Salmonella cases linked to raw, frozen chicken entrees (October 23, 2014). Press release by Minnesota Department of Health/Minnesota Department of Agriculture. 43 FSIS Recall Release (October 24, 2014): Illinois Firm Recalls Chicken Products Due To Salmonella Enteritidis Contamination https:// www.fsis.usda.gov/recalls-alerts/illinois-firmrecalls-chicken-products-due-possible-salmonellaenteritidis. E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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 45 One of the outbreaks included five cases from Minnesota with illness onset dates from May 9, 2015, through July 22, 2015.46 Two of the case patients were hospitalized. All case patients reported consuming various NRTE breaded stuffed chicken products the week before illness onset. All products were produced at the same establishment. In follow-up interviews, two case patients stated that they were aware that the product was raw, three stated that they cooked the product in a conventional oven as instructed on the label, one reported that they used a convection oven/microwave and used a thermometer to confirm that the product reached an internal temperature of 165 °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 2015.47 In addition, in September 2015, FSIS issued a PHA to inform the public that additional NRTE breaded stuffed chicken products produced by the establishment subject to the July 2015 recall had tested positive for the same Salmonella 44 FSIS Salmonella Enteritidis Illness Outbreaks Associated with Raw, Frozen, Stuffed Chicken Products, 2015 After-Action Review Report 2015– 11/2015–12 (December 6, 2016) at: https:// www.fsis.usda.gov/food-safety/foodborne-illnessand-disease/outbreaks/outbreak-investigationsresponse. 45 Minnesota Department of Health: Salmonella cases linked to raw, frozen, stuffed chicken products (July 2, 2015) at: https:// content.govdelivery.com/accounts/MNMDH/ bulletins/10d1df0. 46 CDC: Outbreak of Salmonella Enteritidis Infections Linked to Raw, Frozen, Stuffed Chicken Entrees Produced by Aspen Foods (Final Update) at: https://www.cdc.gov/salmonella/frozen-chickenentrees-part2-07-15/. 47 Aspen Foods Recalls Frozen, Raw, Stuffed and Breaded Chicken Product Due To Possible Salmonella Contamination (July 15, 2015) at: https://www.fsis.usda.gov/recalls-alerts/aspenfoods-recalls-frozen-raw-stuffed-breaded-chickenproducts-due-possible-0#labels. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 Enteritidis strain associated with the outbreak.48 In October 2015, the establishment expanded the July 2015 recall to include an additional 561,000 pounds of products implicated by Salmonella-positive results matching the outbreak strain to prevent additional illnesses.49 The labeling of most of the products subject to the recall stated that the product was raw, should not be cooked in a microwave oven, and provided validated cooking instructions. The label also included instructions to cook the product to a minimum internal temperature of 165 °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.50 Information available from eight case patients indicated that seven of the eight cooked the product in a conventional oven and one used a toaster oven.51 In response, in July 2015, the establishment that produced the implicated product voluntarily recalled approximately 58,320 pounds of various NRTE breaded stuffed chicken products, which was expanded to include additional product for a total of over 1,700,000 pounds of product.52 The labeling of most of the products subject to the recall clearly stated that the product was raw, should not be cooked in a microwave oven, and provided validated cooking instructions. The label also included instructions to cook the product to a minimum internal temperature of 165 °F as measured by a food thermometer and included icons 48 FSIS Issues Public Health Alert for Stuffed Chicken Products Due to Possible Salmonella Contamination (September 17, 2015) at: https:// www.fsis.usda.gov/recalls-alerts/fsis-issues-publichealth-alert-stuffed-chicken-products-due-possiblesalmonella. 49 Aspen Foods Recalls Frozen, Raw, Stuffed and Breaded Chicken Product Due To Possible Salmonella Contamination (October 2, 2015) at: https://www.fsis.usda.gov/recalls-alerts/aspenfoods-recalls-frozen-raw-stuffed-breaded-chickenproducts-due-possible. 50 CDC: Multi-State Outbreak of Drug-Resistant Salmonella Enteritidis Infections Linked to Raw, Frozen, Stuffed Chicken Entrees Produced by Barber Foods (Final Update; October 16, 2015) https://www.cdc.gov/salmonella/frozen-chickenentrees-07-15/.. 51 FSIS outbreak ID 2015–12. 52 Barber Foods Recalls Stuffed Chicken Products Due to Possible Salmonella Enteritidis Contamination (July 12, 2015) at: https:// www.fsis.usda.gov/recalls-alerts/barber-foodsrecalls-stuffed-chicken-products-due-possiblesalmonella-enteritidis. PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 26255 and illustration that emphasized these messages. In 2016, 5 Salmonella Enteritidis cases associated with NRTE breaded stuffed chicken were reported in Minnesota.53 Three of the 5 case patients reported eating NRTE breaded stuffed chicken products purchased at the same retail store, and 2 of those 3 purchased a product brand that was produced by the same establishment. An FSIS investigation found that the retail store had received the same brand of NRTE breaded stuffed chicken products produced by the same establishment during the time in which case patients reported shopping at the retail store. 2015–2016 FSIS and industry response. In response to the 2015 outbreaks and recalls, FSIS issued NOIEs to the two establishments that produced the products associated with the outbreaks to inform them that FSIS intended to withhold marks of inspection or issue a suspension if they did not respond to FSIS within 3 business days regarding how they have or will implement corrective actions.54 55 FSIS also conducted intensified sampling in these establishments for Salmonella, including sampling of comminuted source material, final product, and production environment surface sampling. Both establishments implemented corrective actions, such as source product testing and application of new interventions during processing, that were validated and verified by FSIS. One of the establishments also implemented product labeling changes. In February 2016, FSIS instructed FSIS IPP at establishments that produce raw and heat-treated but not fully cooked, not shelf-stable breaded stuffed chicken products to update the establishments’ Public Health Information System (PHIS) profile to allow FSIS to determine which establishments produce NRTE breaded stuffed chicken products that appear RTE.56 After IPP updated the PHIS profiles, FSIS used the information to schedule a Public Health Risk Evaluation (PHRE) 57 and, if necessary, an FSA at these establishments. FSIS also captured information concerning 53 FSIS outbreak investigation case 2016–06. Establishment P–1358, July 10, 2015. 55 NOIE Establishment P–276, July 10, 2015. 56 FSIS Notice 15–16, Profile Update In Establishments That Produce Not-Ready-To-Eat Stuffed Chicken Products That Appear Ready-To Eat (February 18, 2016). 57 The PHRE is an analysis of establishment performance based on ‘‘For-cause’’ and ‘‘Routine risk-based’’ criteria, https://www.fsis.usda.gov/ policy/fsis-directives/5100.4. 54 NOIE E:\FR\FM\28APN1.SGM 28APN1 26256 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices 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. ddrumheller on DSK120RN23PROD with NOTICES1 2016 National Advisory Committee on Meat and Poultry Inspection Recommendations and National Chicken Council Petition 2016 National Advisory Committee on Meat and Poultry Inspection recommendations. In March 2016, a National Advisory Committee on Meat and Poultry Inspection (NACMPI) subcommittee was charged to consider mandatory labeling features for certain NRTE meat and poultry products that appear RTE.59 The subcommittee met on March 29, 2016, and issued a report that provided recommendations on labeling and other measures to prevent illnesses associated with these products.60 The report recommended, among other things, that the labels of 58 Information on Validation of Labeled Cooking Instructions for Products Containing Raw or Partially Cooked Poultry (February 2017) at: https:// www.fsis.usda.gov/guidelines/2017-0017. 59 National Advisory Committee on Meat and Poultry Inspection, Subcommittee #2 Consideration of Mandatory Labeling Features for Certain Processed Not Ready to Eat Meat and Poultry products. March 26, 2016. (https:// www.fsis.usda.gov/news-and-events/eventsmeetings/2016-national-advisory-committee-meatand-poultry-inspection-nacmpi). 60 Subcommittee #2 Consideration of Mandatory Labeling Features for Certain Processed Not Ready to Eat Meat and Poultry Products (March 2016) (https://www.fsis.usda.gov/sites/default/files/ media_file/2021-02/NRTE-Labeling.pdf). VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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.61 The petition also requests that FSIS issue a guidance document for developing and communicating validated cooking instructions that would incorporate the NCC’s Best Practices for Cooking Instruction Validation for Frozen NRTE Stuffed Chicken Breast Products.62 The petition requests that FSIS establish regulations to require, among other things, that the product name for NRTE breaded stuffed chicken products include the term ‘‘raw;’’ that the principal display panel on the product packaging include statements and icons to signal that the product is raw and should not be cooked in a microwave; and that the labeling provide validated cooking instructions that include a ‘‘do not microwave’’ icon and state that the product must be cooked to a specified endpoint temperature as measured by a food thermometer. FSIS received two letters in support of the petition, one from an industry trade association and one from a consumer advocacy organization.63 The consumer advocacy 61 National Chicken Council petition #16–03, ‘‘Petition to Establish Regulations for the Labeling and Validated Cooking Instructions for Not-Readyto-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-eatstuffed-chicken-products. 62 Attachment 1, National Chicken Council petition #16–03. 63 Letter from Safe Food Coalition dated September 30, 1996 at: https://www.fsis.usda.gov/ PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 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 sites/default/files/media_file/2020-07/16-03Support-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. E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 percent of the study participants were still confused about the raw nature of the product. Consumer Behavior Research 2020 Meal Preparation Experiment. In September 2020, FSIS published a final report on a consumer research study that examined consumers’ use of a food thermometer to check doneness of raw stuffed chicken products prepared from a frozen state.64 FSIS had contracted with RTI International (RTI) and its subcontractor, North Carolina State University (NCSU), to conduct five separate iterations of a meal preparation study to evaluate consumer food handling behaviors in a test kitchen. The study examining participants’ meal preparation related to NRTE breaded stuffed chicken products was the third iteration of the study. It was conducted in a test kitchen facility with individuals who self-reported preparing NRTE breaded stuffed chicken products when cooking at home. The NRTE breaded stuffed chicken product used in the study was packaged to resemble a commercially available product and included the labeling features that manufacturers have voluntarily incorporated into the labeling: i.e., the term ‘‘raw’’ was prominently displayed on the front and back of the product packaging; the principal display panel included statements and icons to signal that the product is raw and should not be cooked in a microwave; and the labeling provided validated cooking instructions that included a ‘‘do not microwave’’ icon as well as icons and instructions to cook the product in a conventional oven to an internal temperature of 165 °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 64 Final Report: Food Safety Consumer Research Project: Meal Preparation Experiment on Raw Stuffed Chicken Breasts (September 23, 2020) at: https://www.fsis.usda.gov/sites/default/files/media_ file/2021-04/fscrp-yr3-nrte-final-report.pdf. 65 Figure 2–2 Packaging for NRTE Chicken Product Used in Meal Preparation Study. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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. Seventysix 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 PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 26257 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, oneuse towel. The study found that approximately 72 percent of participants attempted to wash their hands before beginning meal preparation. Among handwashing attempts, 5 percent of attempts contained all steps of correct handwashing and were considered successful according to the CDC’s criteria. However, during meal preparation, handwashing was attempted only 5 percent of the time that it was required (e.g., after touching the NRTE chicken product), and there were no successful attempts. The study concluded that the small number of handwashing attempts during meal preparation of NRTE breaded stuffed chicken products is likely attributable to participants preparing a raw frozen breaded chicken product rather than fresh raw poultry. Thus, the appearance of NRTE breaded stuffed chicken products and the fact that they are typically cooked from a frozen state may contribute to Salmonella cross contamination in the home. 2022 Study on Appliances Used to Prepare NRTE Breaded Stuffed Chicken Products. In December 2022, the CDC published a report on a study that describes the demographic characteristics of persons who prepare NRTE breaded stuffed chicken products and which appliances they use to prepare them.66 In the study, to assess types of cooking appliances used to prepare NRTE breaded stuffed chicken products, members of an internet research panel were asked to identify 66 Marshall, K.E., Canning, M., Ablan, M., Crawford T.N., Robyn, M. Appliances Used by Consumers to Prepare Frozen Stuffed Chicken Products-United States, May–July 2022. Morb Mortal Wkly Rep Dec 2,2022; 71(48);1511–1516. Available at: https://dx.doi.org/10.15585/ mmwr.mm7148a2. E:\FR\FM\28APN1.SGM 28APN1 26258 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices 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 68 Epidemiologic, laboratory, and traceback data showed that NRTE breaded stuffed chicken products produced by a single establishment were associated with the illnesses. The outbreak included 36 cases from 11 States with illness onset dates from February 21, 2021, to August 16, 2021. Of the 27 case patients interviewed, 14 (52 percent) reported preparing and eating NRTE frozen breaded stuffed chicken products. Of 32 case patients with information available (out of 36 total cases), 12 were hospitalized. No deaths were reported. 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.69 FSIS traced the product purchased by one ill patient to an FSIS-regulated establishment, and on August 9, 2021, the establishment voluntarily recalled approximately 59,251 pounds of the affected products.70 ddrumheller on DSK120RN23PROD with NOTICES1 TABLE 1—SUMMARY OF SALMONELLA OUTBREAK INVESTIGATIONS ASSOCIATED WITH NRTE BREADED STUFFED CHICKEN PRODUCTS 1998–2021 Year Serotype 1998 ................................................ 2005 ................................................ 2005–2006 ...................................... 2006 ................................................ 2008 ................................................ 2008–2009 ...................................... 2009 ................................................ 2009 ................................................ 2013 ................................................ Typhimurium .................................. Heidelberg ...................................... Enteritidis ....................................... Typhimurium .................................. Enteritidis ....................................... I 4,[5],12:i:– .................................... Enteritidis ....................................... Enteritidis ....................................... Enteritidis ....................................... 67 USDA, FSIS: Salmonella Enteritidis Outbreak Linked to Frozen, Raw, Breaded, Stuffed, Chicken Products; Outbreak Investigation After Action Review, Report 2021–07 at: https:// www.fsis.usda.gov/sites/default/files/media_file/ 2022-04/FSIS-After-Action-Review-2021-07.pdf. 68 CDC: Salmonella Outbreak Linked to Raw Frozen Breaded Stuffed Chicken Products (October VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 Illnesses Hospitalization 33 4 27 3 7 47 2 2 3 13, 2021) at: https://www.cdc.gov/salmonella/ enteritidis-06-21/. 69 FSIS Issues Public Health Alert for Frozen, Raw, Breaded Stuffed Chicken Products Due to Possible Salmonella Contamination (June 2, 2021) at: https://www.fsis.usda.gov/recalls-alerts/fsisissues-public-health-alert-frozen-raw-breadedstuffed-chicken-products-due. PO 00000 Frm 00010 Fmt 4703 Sfmt 4703 3 1 6 2 2 8 Recall/PHA Recall. PHA. Recall and PHA. PHA. PHA. 70 Serenade Foods Recalls Frozen, Raw, Breaded, Stuffed Chicken Products Due to Possible Salmonella Contamination (August 9, 2021) at: https://www.fsis.usda.gov/recalls-alerts/serenadefoods-recalls-frozen-raw-breaded-stuffed-chickenproducts-due-possible. E:\FR\FM\28APN1.SGM 28APN1 26259 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices TABLE 1—SUMMARY OF SALMONELLA OUTBREAK INVESTIGATIONS ASSOCIATED WITH NRTE BREADED STUFFED CHICKEN PRODUCTS 1998–2021—Continued Year 2014 2015 2015 2016 2021 Serotype ................................................ ................................................ ................................................ ................................................ ................................................ Enteritidis Enteritidis Enteritidis Enteritidis Enteritidis Illnesses ....................................... ....................................... ....................................... ....................................... ....................................... Hospitalization 6 5 15 5 36 Recall/PHA 1 2 4 Recall and PHA. Recall. Recall and PHA. 12 Recall and PHA. Note: Outbreak investigation data from FSIS at the time the investigations were closed. ddrumheller on DSK120RN23PROD with NOTICES1 2021 NACMPI Recommendations. On August 27, 2021, FSIS announced that the NACMPI would hold a virtual meeting to consider, among other things, issues related to NRTE breaded stuffed chicken products.71 The virtual public meeting was held on September 27 and 28, 2021, and a subcommittee was charged to consider actions FSIS should take to prevent and reduce illnesses associated with the handling or consumption of NRTE breaded stuffed poultry products that may appear RTE to consumers.72 In presenting the charge to the subcommittee, FSIS noted the history of outbreak investigations associated with these products, including the outbreak that resulted in the August 2021 recall, and that these products are labeled as raw and include validated cooking instructions. The Agency also reviewed the results of the consumer research discussed above and noted that FSIS had been petitioned by the NCC in 2016 to establish labeling requirements for NRTE breaded stuffed chicken products and to issue guidance for developing validated cooking instructions. In its charge, FSIS asked the subcommittee to consider several questions on possible measures to address human illnesses associated with NRTE breaded stuffed chicken products. 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 71 National Advisory Committee on Meat and Poultry Inspection, Notification of Public Meeting (86 FR 48115, August 27, 2021) at: https:// www.fsis.usda.gov/sites/default/files/media_file/ 2021-08/FSIS-2021-0019.pdf. 72 2021 National Advisory Committee on Meat and Poultry Inspection Public Meeting at: https:// www.fsis.usda.gov/news-events/events-meetings/ national-advisory-committee-meat-and-poultryinspection-nacmpi-public. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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.73 The subcommittee further recommended that FSIS add label verification for these products as a recurring task for inspectors and review labels from the 2021 outbreak. In addition, the subcommittee recommended that FSIS require establishments that produce these products to reassess their HACCP plans in light of the outbreaks and encouraged FSIS to conduct targeted consumer outreach regarding these types of products, including creating an FSIS web page highlighting NRTE breaded stuffed chicken products. The subcommittee did not reach consensus on whether FSIS should conduct exploratory sampling for indicator organisms or pathogens or whether it should conduct sampling for Salmonella for these products. The subcommittee also did not recommend that FSIS require that establishments apply a lethality treatment to ensure that all NRTE breaded stuffed chicken products are RTE. The subcommittee agreed with the 2016 NCC petition’s request for FSIS to establish requirements for the labeling of NRTE breaded stuffed chicken products and publish industry guidance explaining how to validate cooking instructions for such products and recommended that FSIS take such action. 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 73 National Advisory Committee on Meat and Poultry Inspection: Subcommittee II Stuffed NotReady-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. PO 00000 Frm 00011 Fmt 4703 Sfmt 4703 ‘‘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 E:\FR\FM\28APN1.SGM 28APN1 26260 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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.75 Salmonella is not, however, ordinarily found in the muscle tissue of healthy birds. NRTE breaded stuffed chicken products contain raw, comminuted chicken breast meat, trim, or whole chicken breast meat (i.e., further processed chicken parts or comminuted chicken). FSIS sampling data show that further processed chicken parts (breasts, legs, and wings) and comminuted chicken have a higher incidence of Salmonella compared to carcasses.76 This difference is most 74 United States Department of Agriculture. (October 19, 2021). USDA Launches New Effort to Reduce Salmonella Illness Linked to Poultry. https://www.usda.gov/media/press-releases/2021/ 10/19/usda-launches-new-effort-reduce-salmonellaillnesses-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-salmonellapoultry/pilot. 75 Rimet, C.S., et al. (2019). Salmonella Harborage Sites in Infected Poultry That May Contribute to Contamination of Ground Meat. Frontiers in Sustainable Food Systems 3(2). see also JonesIbarra, A.M., et al. (2019). Salmonella recovery from chicken bone marrow and cecal counts differ by pathogen challenge method. Poult Sci 98(9): 4104– 4112. see also Cox, N.A., et al. (2007). Recovery of Campylobacter and Salmonella Serovars From the Spleen, Liver and Gallbladder, and Ceca of Six-and Eight-Week-Old Commercial Broilers. Journal of Applied Poultry Research 16(4): 477–480. 76 Sampling Results for FSIS-Regulated Products. Available at: https://www.fsis.usda.gov/science- PO 00000 Frm 00012 Fmt 4703 Sfmt 4703 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.81 Additionally, many NRTE breaded stuffed chicken products are made with comminuted chicken. Comminuted products are those that are ground, mechanically separated, or hand- or mechanically deboned and further chopped, flaked, minced, or otherwise processed to reduce particle size. Because of the nature of comminuted processes, Salmonella contamination in chicken skin and bone can spread throughout an entire batch or lot through cross contamination. FSIS sampling data show that ground and other raw comminuted chicken products that were produced using either bone-in or skin-on source materials were more likely to be contaminated with Salmonella than those fabricated from deboned, skinless source materials.82 In addition, Salmonella-negative raw poultry parts and comminuted poultry may become cross-contaminated by contact with Salmonella-contaminated equipment or when they are commingled with Salmonella-positive products, such as when they are collected in combo bins data/sampling-program/sampling-results-fsisregulated-products. 77 FSIS Guidance for Controlling Salmonella in Poultry (June 2021) p. 59. Available at: https:// www.fsis.usda.gov/sites/default/files/media_file/ 2021-07/FSIS-GD-2021-0005.pdf. 78 Codex Guideline for the Control of Campylobacter and Salmonella in Chicken Meat at: https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%25 3A%252F%252Fworkspace. fao.org%252Fsites%252Fcodex %252FStandards%252FCXG%2B782011%252FCXG_078e.pdf. 79 Kim J–W and Slavik M.F. 1996. Cetylpyridinium Chloride (CPC) treatment on poultry skin to reduce attached Salmonella. J. Food Prot. 59: 322–326. 80 Wu D., Alali W.Q., Harrison M.A., and Hofacre C.L. 2014. Prevalence of Salmonella in neck skin and bone of chickens. J Food Prot. 77(7): 1193– 1197. 81 FSIS Guidance for Controlling Salmonella in Poultry (June 2021) pp. 59–60. Available at: https:// www.fsis.usda.gov/guidelines/2021-0005. 82 FSIS Guidance for Controlling Salmonella in Poultry (June 2021) pp. 65–66, Table 4 FSIS exploratory sampling test results, raw comminuted chicken by source material composition (6/1/13–6/ 30/15, 2,688 samples. Available at: https:// www.fsis.usda.gov/guidelines/2021-0005. E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices for further processing.83 84 Salmonellacontaminated 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. ddrumheller on DSK120RN23PROD with NOTICES1 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 nonintact 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. 83 FSIS Guidance for Controlling Salmonella in Poultry (June 2021) pp. 59. Available at: https:// www.fsis.usda.gov/guidelines/2021-0005. 84 Codex Guideline for the Control of Campylobacter and Salmonella in Chicken Meat at https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252 Fworkspace.fao.org%252Fsites%252 Fcodex%252FStandards%252FCXG%2B782011%252FCXG_078e.pdf. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 Because FSIS has tentatively concluded that Salmonella is an added substance in NRTE breaded stuffed chicken products, the Agency has tentatively concluded that these products are adulterated when they contain Salmonella at levels of 1 CFU per gram or higher because Salmonella at these levels ‘‘may render’’ NRTE breaded stuffed chicken products injurious to health (21 U.S.C. 453(g)(1)).85 Moreover, FSIS is proposing to declare that NRTE breaded stuffed chicken products that are contaminated with Salmonella at levels of 1 CFU per gram or above are adulterated within the meaning of 21 U.S.C. 453(g)(3) because when they contain Salmonella at these levels, NRTE breaded stuffed chicken products present a sufficiently serious risk of causing human Salmonella illnesses such as to make them unhealthful, unwholesome, or otherwise unfit for human food. The basis for this proposed determination is discussed below. 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 85 The adulteration definition in 21 U.S.C. 453(g)(1) includes two separate standards for determining whether a product is adulterated. Under 21 U.S.C. 453(g)(1), if a substance is an ‘‘added substance’’ the product is adulterated if the substance ‘‘may render’’ the product injurious to health. If the substance is not added, the product is adulterated ‘‘if the quantity of such substance in or on’’ the product ‘‘ordinarily’’ renders it injurious to health. As discussed in this document, FSIS has tentatively concluded that when present in NRTE breaded stuffed chicken products, Salmonella at 1 CFU per gram or higher meets the definition of an ‘‘added substance’’ that ‘‘may render’’ these products injurious to health. Although the ‘‘may render’’ standard is the primary basis for FSIS’ tentative determination that the product is adulterated, FSIS also believes that NRTE breaded stuffed chicken products that contain Salmonella at 1 CFU per gram or higher meet the more stringent ‘‘ordinarily injurious’’ standard for substances that are not added because ordinary consumer handling and preparation, as reported in outbreak investigations and consumer research, may not reduce Salmonella to levels that do not result in illness and may also contribute to crosscontamination when these products are prepared in the home. PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 26261 products.86 Serotypes Typhimurium, Enteritidis, Blockley, and Infantis account for 92 percent of the outbreak related illnesses. These 4 serotypes account for 77.4 percent of 1,946 illnesses reported in the National Outbreak Reporting System due to Salmonella from chicken during the years 2015–2019 (61 outbreaks).87 Approximately 2,500 Salmonella serotypes have been identified,88 though not all serotypes have been isolated from chicken. Almost all strains of Salmonella are pathogenic as they have the ability to invade, replicate and survive in human host cells, resulting in potentially fatal disease,89 though not all are equally likely to cause illness. Additionally, according to the CDC, reported cases from outbreaks only represent a fraction of actual cases.90 Thus, because the reported outbreaks represent a small portion of Salmonella illnesses, the serotypes that have been found to be associated with Salmonella outbreaks do not capture all serotypes that are causing illnesses. 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 86 FSIS Outbreak Reports at: https:// www.fsis.usda.gov/food-safety/foodborne-illnessand-disease/outbreaks. 87 Centers for Disease Control and Prevention: National Outbreak Reporting System at: https:// wwwn.cdc.gov/norsdashboard/. 88 Brenner F.W., Villar R.G., Angulo F.J., Tauxe R., Swaminathan B. Salmonella nomenclature. J Clin Microbiol. 2000 Jul;38(7):2465–7. doi: 10.1128/ JCM.38.7.2465–2467.2000. PMID: 10878026; PMCID: PMC86943. 89 Shu-Kee Eng, Priyia Pusparajah, NurulSyakima Ab Mutalib, Hooi-Leng Ser, Kok-Gan Chan & Learn-Han Lee (2015) Salmonella: A review on pathogenesis, epidemiology and antibiotic resistance, Frontiers in Life Science, 8:3, 284–293, DOI: 10.1080/21553769.2015.1051243 90 Scallan, E., Hoekstra, R.M., Angulo, F.J., Tauxe, R.V., Widdowson, M., Roy, S.L. Griffin, P.M. (2011). Foodborne Illness Acquired in the United States— Major Pathogens. Emerging Infectious Diseases, 17(1), 7–15. https://doi.org/10.3201/ eid1701.p11101; Mead, P.S., et al., Food-related illnesses and deaths in the United States. Emerging Infect Dis, Oct1999. 5(5) p. 607–625. E:\FR\FM\28APN1.SGM 28APN1 26262 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 variations in gene sequence and expression. In an August 2018 report, the NACMCF was unable to find evidence in the literature for any determinant that correlated with high virulence in human foodborne disease.91 The NACMCF noted that a few Salmonella serotypes are consistently associated with the greatest incidence of human disease. However, this disparity among serotypes may be related to survival in animal hosts or during food harvesting and processing rather than serotype-specific differences in human virulence. FSIS seeks to better understand Salmonella characteristics, including virulence, and actively engages in and encourages research in this area. In October 2021, FSIS launched a new effort aimed at developing a stronger and more comprehensive framework for reducing Salmonella illnesses associated with poultry products.92 As part of this initiative, FSIS will leverage USDA’s strong research 93 capabilities and strengthen its partnership with the USDA Research Education and Economics 94 mission area to address data gaps and develop new laboratory methods to guide future Salmonella policy. FSIS is also exploring more efficient methods to enumerate pathogens in samples, detect virulence factors in pathogens, and investigate new pathogen characterization methods. As science and laboratory technologies advance, FSIS will continue to use the most innovative and sensitive methods available to protect public health. 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 91 NACMCF (2019). Response to Questions Posed by the Food Safety and Inspection Service Regarding Salmonella Control Strategies in Poultry. Journal of Food Protection 82(4): 645–668. 92 USDA Launches New Effort to Reduce Salmonella Linked to Poultry (October 19, 2021) at: https://www.usda.gov/media/press-releases/2021/ 10/19/usda-launches-new-effort-reduce-salmonellaillnesses-linked-poultry. 93 FSIS Food Safety Research Priorities and Studies, available at https://www.fsis.usda.gov/ science-data/research-priorities#:∼:text=FSIS %20Data%20Gaps%20%20%20%20Study %20Title,may%20survi%20...%20 %209%20more%20rows%20?msclkid= f7030eaea6c411ec9e91f63d1dde98ff. 94 USDA Research, Education, and Economics website, available at: https://www.ree.usda.gov/ #:∼:text=The%20Research%2C%20Education%2C %20and%20Economics%20%28 REE%29%20mission%20area, and%20youth%20through%20 integrated%20research%2C%20 analysis%2C%20and%20education.? msclkid=261bd671a6c411eca6c1c87daaae90cd. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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 serotypespecific 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 PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 investigations associated with a variety of food products have been used to estimate the relationship between the number of organisms consumed and the probability of illness. Five Salmonella foodborne outbreaks have shown that Salmonella can cause illness from exposure of 10 or fewer organisms per person.95 Additionally, several outbreaks from a range of Salmonella serotypes in various food products have shown that exposure from 11 to 420 organisms per person can result in illness.96 Thus, in these published studies, the infectious dose ranged from 1 to 420 Salmonella organisms per person. Using a dose-response model approach utilizing outbreak data, and accounting for variation among 95 Killalea, D., et al., International Epidemiological and Microbiological Study of Outbreak of Salmonella Agona Infection from a Ready to Eat Savoury Snack—I: England and Wales and the United States. 1996, British Medical Journal Publishing Group.; Shohat, T., et al., International Epidemiological and Microbiological Study of Outbreak of Salmonella Agona Infection from a Ready to Eat Savoury Snack—Ii: Israel. BMJ, 1996. 313(7065): p. 1107–1109.; D’aoust, J.Y. and J.Y.D. Aoust, Infective Dose of Salmonella Typhimurium in Cheddar Cheese. American Journal of Epidemiology, 1985. 122(4): p. 717–720.; D’aoust, J.Y., D.W. Warburton, and A.M. Sewell, Salmonella Typhimurium Phage-Type 10 from Cheddar Cheese Implicated in a Major Canadian Foodborne Outbreak. Journal of Food Protection, 1985. 48(12): p. 1062–1066.; Kapperud, G., et al., Outbreak of Salmonella Typhimurium Infection Traced to Contaminated Chocolate and Caused by a Strain Lacking the 60-Megadalton Virulence Plasmid. J Clin Microbiol, 1990. 28(12): p. 2597–601.; Hockin, J.C. et al., An International Outbreak of Salmonella Nima from Imported Chocolate. J Food Prot. 1989. 52(1): p. 51–54.; Lehmacher, A., Bockemuhl, J., and Aleksic. S. Nationwide outbreak of human salmonellosis in Germany due to contaminated paprika and paprika-powdered potato chips. 1995. Epidemiol Infect. 115: p. 501–11. 96 Kasuga F. et al., Archiving of food samples from restaurants and caterers—Quantitative profiling of outbreaks of foodborne salmonella in Japan. Journal of Food Protection, 2004. 67: p. 2024–2032; Blaser, M.J., and Newman, L.S. A review of human salmonellosis: I. Infective dose. Rev Infect Dis., 1982.4: p.1096–106; Abe, K., N. et al., Prolonged incubation period of Salmonellosis associated with low bacterial doses. Journal of food protection, 2004. 67: p. 2735–2740; Hara-Kudo, Y. and K. Takatori, Contamination level and ingestion dose of foodborne pathogens associated with infections. Epidemiology and Infection, 2011. 139: p. 1505–1510; Hennessy T.W., et al., A national outbreak of Salmonella enteritidis infections from ice cream. N Engl J Med, 1996. 334(20): p. 1281– 6; Hedberg C.W., et al., A multistate outbreak of Salmonella javiana and Salmonella oranienburg infections due to consumption of contaminated cheese. JAMA, 1992. 268(22): p. 3203–7; Todd, E.C., et al., Outbreaks where food workers have been implicated in the spread of foodborne disease. Part 4. Infective doses and pathogen carriage. J Food Prot, 2004. 71: p. 2339–73; Scheil W., et al., A South Australian Mdbandaka outbreak investigation using a database to select controls. Aust NZ J Public Health, 1998. 22(5): p. 536–9; Tamber, S., E. Swist, and D. Oudit, Physicochemical and bacteriological characteristics of organic sprouted chia and flax seed powders implicated in a foodborne Salmonellosis outbreak. Journal of Food Protection, 2016. 79(5): p. 703–709. E:\FR\FM\28APN1.SGM 28APN1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices 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 × 107 CFU).97 The median illness dose refers to the dose at which 50% of individuals in an exposed population will experience symptomatic illness. The average median illness dose and its prediction interval reflect variability among outbreak strains and exposed populations and uncertainty about the dose-response relationship. A similar dose-response approach was developed by the World Health Organization Food and Agriculture Organization of the United Nations for risk assessments for Salmonella in eggs and broiler chickens.98 Also using outbreaks, the model estimated a 13 percent chance of becoming ill if ingesting 100 organisms. Even at the level of 1 organism ingested, there was still a non-zero chance of illness (0.25 percent). These Salmonella outbreaks as well as dose-response modeling of Salmonella outbreaks, suggest that exposure to a small number of Salmonella organisms can result in foodborne illness. Assuming a minimum of 0.5 log (68%) Salmonella reduction likely achieved with even partial cooking, the proposed level of 1 CFU per gram (assuming a typical 70– 88 gram portion size) should significantly mitigate the risk of illness associated with NRTE breaded stuffed chicken products. Taking into account: (1) the range of infectious doses referenced above (between 1–420 CFU), in particular that a Salmonella dose-response model based on outbreaks showed the average Salmonella median illness dose was 36 CFU; (2) that most consumers will cook NRTE breaded stuffed chicken products to some degree, resulting in mitigation of the exposure to the pathogen; (3) that the average chicken portion in a NRTE breaded stuffed chicken product is approximately 70–88 grams; 99 and (4) that, at this point, technology does not exist to identify serotype pathogenicity factors in a timely manner, FSIS has tentatively concluded that Salmonella, at a concentration lower than 1 CFU per gram, would not ordinarily render this type of NRTE commodity injurious to health or make them unwholesome, unhealthful or otherwise unfit for 97 Teunis P.F., et al., Dose-response modeling of Salmonella using outbreak data. Int J Food Microbiol, 2010. 144(2): p. 243–9. 98 World Health Organization, Risk assessment of Salmonella in eggs and broiler chickens, March 25, 2002. Available at: https://www.who.int/ publications/i/item/9291562293. 99 Based on product formulation information. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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 nonintact beef products, the Agency considered the severity of the consequences of an infection with these pathogens and noted that they had been linked with serious, life-threatening human illnesses, such as hemorrhagic colitis and HUS. Although the symptoms of Salmonella infections are typically not reported to be as severe as those associated with STEC, Salmonella can cause bloody diarrhea, fever, abdominal cramps, nausea, and vomiting. In some instances, Salmonella enters the blood and makes its way to other areas of the body including, but not limited to, the heart, lung, bone, joints and the central nervous system.100 This can result in severe illness requiring hospitalizations and even death, especially in vulnerable populations, such as very young, elderly, and immunocompromised individuals. Even when Salmonella is no longer detectable in the body, prior Salmonella illness has also been associated with an increased risk in colon cancer.101 And can cause debilitating, long-lasting conditions including inflammatory bowel disease, irritable bowel syndrome and reactive arthritis. Furthermore, a study that allows for a comparison of case-fatality proportions of both Salmonella and STEC O157 demonstrates a higher frequency of deaths among Salmonella cases than among STEC O157 cases.102 The estimated annual domestic foodborne illnesses reported in the study were 1,027,561 and 63,153 for Salmonella and STEC O157, respectively. Annual deaths from domestic foodborne illnesses are 378 and 20 for Salmonella and STEC O157, respectively. Therefore, Salmonella deaths occur at a frequency of 4 per 10,000 illnesses, while STEC 100 Batz, M.B., et al., Long-Term consequences of foodborne illness. Infect Dis Clin North Am, Sept 2013. 28(3) p. 599–661; Hohmann, E.L., Nontyphoidal Salmonellosis, Clin Infect Dis, Sept 2001. 32 p. 263–269; Heymann, D. Salmonellosis. Control of Communicable Disease Manual, 2021. 101 Mughini-Gras, L. et al. Increased colon cancer risk after severe Salmonella infection. PLoS ONE, 2018. 13(1): p. 1–19. https://doi.org/10.1371/ journal.pone.0189721. 102 Scallan, et al., 2011. PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 26263 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 multistate 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 nonintact 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 103 Scallan, et al. 2011; Mead, P.S., et al., Foodrelated illnesses and deaths in the United States. Emerging Infect Dis, Oct1999. 5(5) p. 607–625. E:\FR\FM\28APN1.SGM 28APN1 ddrumheller on DSK120RN23PROD with NOTICES1 26264 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices 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 VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 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 E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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.105 When sampling the chicken component of NRTE breaded stuffed chicken products under this proposed determination, FSIS would collect one pound of the chicken component prior to stuffing and breading from the establishment to analyze 325 grams per test for Salmonella. Samples would be initially screened, post-enrichment, for the presence or absence of Salmonella. Samples that screen negative would be reported as ‘‘negative.’’ For samples that screen positive, FSIS would use selective and differential culture-based media and proteomics testing to identify the presumptive positive samples. All presumed positive samples would be subject to confirmatory tests and 104 This information would be reported as with any test result. Inspectors would get result through PHIS. FSIS would report out through Laboratory Information Management System (LIMS) Direct for industry as well as the result would be in the new PHIS sample result history report. The results would also be in public release data sets that the agency does quarterly. The WGS data would also be uploaded to NCBI as are other Salmonella isolates. 105 FSIS Microbiology Laboratory Guidebook available at: https://www.fsis.usda.gov/news-events/ publications/microbiology-laboratory-guidebook. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 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 106 For 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–UPTM QUANT Salmonella,’ into the Agency’s laboratory system. The Agency evaluated commercially available quantification systems and determined that this technology is the most appropriate for use in the high throughput FSIS laboratory environment. FSIS stated that in the future, the Agency would announce when the method is available and when it will be implemented in all three FSIS food testing laboratories. FSIS also stated that it plans to extend pathogen quantification technology to sample types other than raw poultry rinses in the future (see FSIS Constituent Update, Jul 8, 2022, FSIS to include Salmonella Quantification in Raw Poultry Rinse Samples. Available at: https://www.fsis.usda.gov/ news-events/news-press-releases/constituentupdate-july-8-2022#:∼:text=Salmonella%20 quantification%20is%20a%20significant %20step%20in%20FSIS%E2%80%99,regulatory %20sample%2C%20not%20 solely%20its%20presence%20or%20absence. PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 26265 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.109 These rates are higher than the Salmonella-positive rates for other raw chicken products, which suggests that NRTE breaded stuffed chicken products and ground chicken have a higher risk per serving than other raw chicken products. However, consumer preparation practices are more likely to mitigate the risk associated with ground chicken because, unlike NRTE breaded stuffed chicken products, ground chicken 107 FSIS Outbreak Reports at: https:// www.fsis.usda.gov/food-safety/foodborne-illnessand-disease/outbreaks. 108 Centers for Disease Control and Prevention: National Outbreak Reporting System at: https:// wwwn.cdc.gov/norsdashboard/. 109 USDA Food Safety and Inspection Service Annual Sampling Report Fiscal Year 2021: https:// www.fsis.usda.gov/sites/default/files/media_file/ 2022-02/FY2021-Sampling-Summary-Report.pdf. E:\FR\FM\28APN1.SGM 28APN1 26266 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 maintain the integrity of the sampled chicken component lot pending the availability of test results. Under any final verification sampling plan, FSIS IPP would give establishments that produce NRTE breaded stuffed chicken product advance notice before they collect a product sample from the chicken component for Salmonella to give the establishment enough time to control the sampled lot. The sampled lot is the product represented by the sample collected and analyzed by FSIS. Establishments are responsible for providing a supportable basis for defining the sample lot. For sampling purposes, product lots should be defined such that they are microbiologically independent. Microbiological independence is documented by separation, e.g., physical, temporal, or by sanitation intervention, that clearly delineates the end of one production lot and the beginning of the next. The microbiological results from one test are independent of prior or later lots. In other words, under this proposed verification plan, if a chicken component sample collected prior to stuffing and breading tests positive for Salmonella at a level of 1 CFU per gram or higher, products from other chicken component lots should not be implicated. Generally, FSIS recommends that establishments develop and implement in-plant sampling plans that define production lots or sub-lots that are microbiologically independent of other production lots or sub-lots. Production lots that are so identified may bear distinctive markings on the shipping cartons. FSIS has issued guidance to help establishments comply with the Agency’s policy that does not allow product that FSIS has tested for adulterants to enter commerce until test results become available.110 In addition to providing guidance on adequate control measures establishments can implement for products tested for adulterants, the document also includes guidance on how establishments can define a product lot in order to determine the amount of product that must be controlled pending test results. If FSIS finalizes its proposed Salmonella verification sampling for NRTE breaded stuffed chicken product, FSIS would update the guidance to cover Salmonella sampling of the chicken component of NRTE breaded 110 FSIS Compliance Guideline: Controlling Meat and Poultry Product Pending FSIS Test Results (2013) at: https://www.fsis.usda.gov/guidelines/ 2013-0003. PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 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 postmortem inspection, reinspection, and sanitation requirements that are at least equal to those in the Federal Meat Inspection Act (21 U.S.C. 661(a)(1)). Therefore, if FSIS finalizes this proposed determination, these States would need to adopt sampling procedures and testing methods to detect Salmonella at 1 CFU/gram or above in the chicken component in NRTE breaded stuffed chicken products that are at least equal to FSIS’ procedures and testing methods for State-inspected establishments that produce these products.111 Any State participating in a Cooperative Interstate Shipment Program would need to adopt FSIS’ sampling procedures and testing methods to detect Salmonella at 1 CFU/ gram or above in NRTE breaded stuffed chicken products in selected establishments that produce these products for shipment in interstate commerce (21 U.S.C. 472). Foreign countries that are eligible to export poultry products to the United States must apply inspection, sanitary, and 111 FSIS is not aware of any State-inspected establishments that produce NRTE stuffed chicken products. E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices 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. ddrumheller on DSK120RN23PROD with NOTICES1 Summary of Estimated Costs and Benefits If finalized, this proposed determination is expected to impact six domestic establishments and cost industry at least $4.33 million annually, assuming a 7 percent discount rate over a ten-year period.112 These costs are associated with HACCP plan reassessments, holding sampled chicken components in cold storage awaiting test results, and the costs associated with developing and implementing an establishment-conducted sampling program. To varying degrees, industry may also incur costs associated with their individual responses to this policy. The Agency would incur costs associated with sampling and testing for Salmonella and conducting FSAs. However, these costs are likely more than offset by consumer and industry benefits. The benefit from reduced outbreakrelated 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 outbreakrelated recall being $25.85 million, total benefits would exceed total costs if the proposed determination prevents at least 1 outbreak-related recall every 5.96 112 FSIS used its Public Health Information System (PHIS) data accessed on 07/28/2022. VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 years ($25.85/$4.33).113 Although the proposed policy may not prevent every possible Salmonella-related outbreak or illness in these products, FSIS believes the benefits of the proposed policy would exceed the costs if the policy contributes to preventing at least 1 outbreak-related recall every 60 months.114 Between 2006 and 2021 there was one outbreak every 16.4 months average (15 years/11 outbreaks). Also, according to the CDC, reported cases from outbreaks only represent a fraction of actual cases; therefore, the health benefits associated with this new policy is likely to be higher than estimated in the published CBA.115 Potential Impact on Small Businesses In the CBA, FSIS defines high-volume establishments as establishments that produce at least 1 million pounds of NRTE stuffed chicken products annually and low-volume establishments as establishments that produce less than 1 million pounds annually. Using these categories, three of the six establishments that produce NRTE stuffed chicken products were classified as high-volume, and three establishments as low-volume. All three of the low-volume establishments are HACCP size small or very small.116 FSIS expects the cost burden of this proposed determination on low-volume establishments would be small. Nearly 90 percent of production at these three low-volume establishments is product other than NRTE stuffed chicken products. These establishments would choose to incur costs based on their own economic rationale. 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 113 Numbers may not calculate due to rounding. rounded to the nearest month. 115 Scallan, E., Hoekstra, R.M., Angulo, F.J., Tauxe, R.V., Widdowson, M., Roy, S.L. Griffin, P.M. (2011). Foodborne Illness Acquired in the United States—Major Pathogens. Emerging Infectious Diseases, 17(1), 7–15. https://doi.org/10.3201/ eid1701.p11101. 116 Under the HACCP size definitions, large establishments have 500 or more employees, small establishments have between 10 and 499 employees, and very small establishments have less than 10 employees or less than $2.5 million in annual revenue. 61 FR 38806. 114 Numbers PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 26267 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/electronicforms, 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. 117 Grants and Financial Options, USDA FSIS https://www.fsis.usda.gov/inspection/apply-grantinspection/grants-financial-options. E:\FR\FM\28APN1.SGM 28APN1 26268 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices 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 Running total ddrumheller on DSK120RN23PROD with NOTICES1 1 2 3 4 5 6 7 8 9 ................... ................... ................... ................... ................... ................... ................... ................... ................... Data source 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: Year Poultry type ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... Product ................. ................. ................. ................. ................. ................. ................. CDC CDC CDC CDC CDC CDC CDC NORS NORS NORS NORS NORS NORS NORS ................ ................ ................ ................ ................ ................ ................ 1999 1999 1999 1999 1999 1999 1999 Chicken Chicken Chicken Chicken Chicken Chicken Chicken ....................... ....................... ....................... ....................... ....................... ....................... ....................... 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ 1999 1999 2000 2000 2000 2000 2000 2001 2001 2001 2001 2001 2001 2001 2001 2002 2002 2002 2003 Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... 36 ................. 37 ................. CDC NORS ................ CDC NORS ................ 2003 2003 Chicken ....................... Chicken ....................... 38 39 40 41 42 43 44 45 46 47 48 49 50 51 CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ 2003 2003 2003 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken chicken, chicken, chicken, chicken, chicken, chicken, chicken, chicken, chicken, chicken, chicken, chicken, chicken, chicken, CDC NORS ................ CDC NORS ................ 2004 2005 Chicken ....................... Chicken ....................... VerDate Sep<11>2014 Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Appendix A: Salmonella Outbreak Investigations Associated With All Chicken Products 1998–2020 10 11 12 13 14 15 16 52 ................. 53 ................. 1998 1998 1998 1998 1998 1998 1999 1999 1999 Paul Kiecker, Administrator. chicken, unspecified ...................... chicken .......................................... chicken .......................................... chicken, unspecified ...................... chicken, unspecified ...................... chicken Kiev .................................. chicken salad ................................. chicken, unspecified ...................... chicken, unspecified; mung bean sprouts. chicken, unspecified ...................... chicken, baked .............................. chicken, unspecified ...................... chicken, bbq .................................. chicken, unspecified ...................... chicken, other ................................ burrito, chicken; taco, chicken; chicken, nuggets/fingers. deli meat, sliced chicken ............... chicken, unspecified ...................... chicken, unspecified ...................... chicken, bbq .................................. chicken, fried ................................. chicken, unspecified ...................... chicken, unspecified ...................... chicken, grilled ............................... chicken, nuggets/fingers ................ chicken, baked .............................. chicken, fried ................................. specialty salads unspecified .......... chicken, other ................................ chicken, other ................................ chicken, other ................................ chicken .......................................... chicken, other ................................ chicken, baked .............................. sauces, unspecified; chicken, unspecified. chicken, baked .............................. chicken, baked .............................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ PubMed ...................... CDC NORS ................ CDC NORS ................ CDC NORS ................ 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. NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS 18:44 Apr 27, 2023 Jkt 259001 PO 00000 Frm 00020 ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... Fmt 4703 Sfmt 4703 unspecified ...................... other ................................ roasted ............................ raw .................................. roasted ............................ curry ................................ baked .............................. other ................................ unspecified ...................... unspecified ...................... other ................................ baked .............................. other ................................ grilled ............................... chicken, unspecified ...................... chicken, grilled ............................... E:\FR\FM\28APN1.SGM 28APN1 Subtype Enteritidis. Enteritidis. Enteritidis. Group E1. Typhimurium. Typhimurium. Enteritidis. Enteritidis. Enteritidis. Give. Hadar. Hadar. Heidelberg. Javiana. Muenchen. Typhimurium. Unsubtyped. Unsubtyped. Group B. Group C1. Newport. Newport. Typhimurium. Braenderup. Enteritidis. Enteritidis. Newport. Typhimurium. Typhimurium. Unsubtyped. Unsubtyped. Enteritidis. Rubislaw. Unsubtyped. Enteritidis. Enteritidis. Newport; Muenster; Heidelberg. Typhimurium. Unsubtyped. Unsubtyped. Enteritidis. Group B. Group D1. Hadar. Heidelberg. Heidelberg. Heidelberg. Thompson. Typhimurium. Typhimurium. Typhimurium var Cope. Unsubtyped. Enteritidis. 26269 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices Running total Data source 54 ................. CDC NORS ................ 55 ................. 56 ................. Poultry type Product 2005 Chicken ....................... CDC NORS ................ CDC NORS ................ 2005 2005 Chicken ....................... Chicken ....................... stuffing/dressing; gravy, chicken; chicken, other. chicken, grilled ............................... stuffed chicken .............................. 57 ................. 58 ................. CDC NORS ................ CDC NORS ................ 2005 2005 Chicken ....................... Chicken ....................... 59 60 61 62 63 CDC CDC CDC CDC CDC ................ ................ ................ ................ ................ 2005 2006 2006 2006 2006 Chicken Chicken Chicken Chicken Chicken 64 ................. PubMed ...................... 2006 Chicken ....................... 65 ................. CDC NORS ................ 2006 Chicken ....................... 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS FSIS/NORS CDC NORS CDC NORS ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ 2007 2007 2007 2007 2007 2007 2008 2008 2008 2008 2009 2009 2009 2009 2010 Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... 81 82 83 84 ................. ................. ................. ................. CDC CDC CDC CDC NORS NORS NORS NORS ................ ................ ................ ................ 2010 2010 2010 2010 Chicken Chicken Chicken Chicken ....................... ....................... ....................... ....................... chicken, bbq .................................. chicken dishes, unspecified .......... ribs, bbq; chicken wings, bbq ........ Not RTE frozen chicken pot pie .... chicken .......................................... chicken, baked; chicken, grilled .... specialty/ethnic dishes .................. chicken, roasted ............................ chicken, other ................................ chicken, unspecified ...................... chicken .......................................... chicken .......................................... Stuffed chicken .............................. chicken .......................................... Cheesy Chicken and Rice frozen meals (frozen entre´e). chicken and rice ............................ chicken salad ................................. chicken .......................................... chicken, baked .............................. 85 86 87 88 89 90 ................. ................. ................. ................. ................. ................. CDC CDC CDC CDC CDC CDC NORS NORS NORS NORS NORS NORS ................ ................ ................ ................ ................ ................ 2011 2011 2011 2011 2011 2011 Chicken Chicken Chicken Chicken Chicken Chicken ....................... ....................... ....................... ....................... ....................... ....................... chicken .......................................... chicken picata ................................ chicken .......................................... Kosher Broiled Chicken Livers ...... chicken, other ................................ chicken .......................................... CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ FSIS/NORS ................ CDC NORS ................ CDC NORS ................ CDC SNORS .............. CDC NORS ................ CDC NORS ................ CDC SNORS .............. CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ FSIS/NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ 2012 2012 2012 2012 2012 2012 2012 2013 2013 2013 2013 2013 2013 2013 2013 2013 2014 2014 2014 2014 2014 2014 2014 2014 Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... chicken .......................................... fajita, chicken ................................. chicken .......................................... chicken, baked .............................. chicken .......................................... chicken .......................................... chicken .......................................... Stuffed chicken .............................. chicken .......................................... ground chicken .............................. Mechanically Separated Chicken .. chicken .......................................... chicken mole ................................. chicken products ........................... chicken .......................................... chicken, bbq .................................. chicken .......................................... chicken .......................................... chicken .......................................... chicken, casserole ......................... stuffed chicken (chicken kiev) ....... chicken liver pate .......................... chicken .......................................... chicken, smoked ............................ ................. ................. ................. ................. ................. 91 ................. 92 ................. 93 ................. 94 ................. 95 ................. 96 ................. 97 ................. 98 ................. 99 ................. 100 ............... 101 ............... 102 ............... 103 ............... 104 ............... 105 ............... 106 ............... 107 ............... 108 ............... 109 ............... 110 ............... 111 ............... 112 ............... 113 ............... 114 ............... VerDate Sep<11>2014 NORS NORS NORS NORS NORS 18:44 Apr 27, 2023 Jkt 259001 Year PO 00000 Frm 00021 ....................... ....................... ....................... ....................... ....................... Fmt 4703 Sfmt 4703 chicken, other ................................ stuffed chicken (Chicken Broccoli and Cheese). chicken, other ................................ chicken .......................................... chicken, baked .............................. chicken, unspecified ...................... chicken, teriyaki; sushi, unspecified. Chicken Kiev, Chicken Broccoli and Cheese, Chicken Mushrooms and Cheddar, Chicken Mushrooms in Wine Sauce, and/or Chicken Romanov. chicken, unspecified ...................... E:\FR\FM\28APN1.SGM 28APN1 Subtype Enteritidis. Enteritidis. Enteritidis; Typhimurium; Kentucky. Heidelberg. Heidelberg. Unsubtyped. Agona. I 4,[5],12:i:-. Newport. Typhimurium. Typhimurium. Typhimurium var Cope. Braenderup. Enteritidis. Enteritidis. I 4,[5],12:i:-. Schwarzengrund. Typhimurium. Enteritidis. Typhimurium. Typhimurium. Typhimurium. Heidelberg. Heidelberg. 1 4,[5], 12:i-. Typhimurium. Chester. Enteritidis. Enteritidis. Heidelberg. Typhimurium var Cope. Enteritidis. Enteritidis. Enteritidis. Heidelberg. Montevideo. Typhimurium var Cope. Enteritidis. Enteritidis. Heidelberg. Javiana. Newport. Schwarzengrund. Unsubtyped. Enteritidis. Enteritidis. Enteritidis. Heidelberg. Heidelberg. Heidelberg. Heidelberg. Javiana. Montevideo. Carmel. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis; Enteritidis. Heidelberg. 26270 Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices Running total ddrumheller on DSK120RN23PROD with NOTICES1 115 116 117 118 119 120 121 122 123 ............... ............... ............... ............... ............... ............... ............... ............... ............... Data source Poultry type ................ ................ ................ ................ ................ ................ ................ ................ ................ 2014 2014 2014 2014 2015 2015 2015 2015 2015 Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken 124 ............... 125 ............... FSIS/NORS ................ CDC NORS ................ 2015 2015 Chicken ....................... Chicken ....................... 126 ............... 127 ............... CDC NORS ................ CDC NORS ................ 2015 2015 Chicken ....................... Chicken ....................... 128 129 130 131 CDC NORS FSIS/NORS CDC NORS CDC NORS ................ ................ ................ ................ 2015 2016 2016 2016 Chicken Chicken Chicken Chicken 132 ............... 133 ............... CDC NORS ................ CDC NORS ................ 2016 2016 Chicken ....................... Chicken ....................... 134 135 136 137 138 139 140 141 142 143 144 ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC CDC ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ ................ 2016 2016 2016 2016 2016 2017 2017 2017 2017 2017 2017 Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ FSIS/NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDCNORS .................. CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ CDC NORS ................ 2017 2017 2017 2017 2017 2018 2018 2018 2018 2018 2018 2018 2018 2018 2018 2018 2018 2018 2018 2019 2019 2019 2019 2019 2019 2019 2019 2019 2019 2019 2019 2020 2020 2020 Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken Chicken ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ............... ............... ............... ............... VerDate Sep<11>2014 CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS CDC NORS FSIS/NORS Year NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS NORS 18:44 Apr 27, 2023 Jkt 259001 PO 00000 Frm 00022 ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... Fmt 4703 Sfmt 4703 Product chicken, grilled ............................... chicken .......................................... chicken, smoked ............................ sandwich, chicken ......................... chicken, rotisserie .......................... chicken, rotisserie .......................... Stuffed chicken .............................. chicken tenders ............................. frozen, raw, stuffed and breaded chicken. chicken Kiev, cordon bleu, ............ chicken, grilled; chicken, blackened. chicken and waffles ....................... chicken katsu plate; korean chicken. chicken, roasted ............................ Stuffed chicken .............................. pate, chicken liver ......................... chicken, baked .............................. chicken .......................................... rotisserie chicken salad from Costco’s Alderwood store. chicken .......................................... chicken .......................................... chicken .......................................... chicken .......................................... chicken .......................................... sandwich, chicken ......................... chicken .......................................... chicken .......................................... chicken dishes ............................... kabobs, chicken ............................. chicken salad sandwich; grilled chicken salad; chicken caesar salad. chicken .......................................... chicken .......................................... chicken, pulled ............................... chicken .......................................... chicken, smoked ............................ chicken, raw .................................. chicken .......................................... chicken, grilled ............................... chicken .......................................... raw breaded chicken ..................... chicken, smoked ............................ smoked chicken ............................. chicken, other ................................ chicken .......................................... chicken, raw .................................. kosher chicken .............................. chicken .......................................... chicken salad ................................ chicken .......................................... chicken .......................................... chicken .......................................... chicken .......................................... chicken .......................................... chicken fingers .............................. chicken .......................................... chicken .......................................... mechanically separated chicken ... chicken .......................................... chicken products ........................... chicken .......................................... chicken .......................................... chicken .......................................... chicken .......................................... chicken .......................................... E:\FR\FM\28APN1.SGM 28APN1 Subtype Heidelberg. Infantis. Thompson. Thompson. Braenderup. Derby. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Muenchen. Unsubtyped. Enteritidis. Enteritidis. Enteritidis; Enteritidis; Enteritidis. Heidelberg. I 4,[5],12:i:-. Muenchen. Norwich. Saintpaul. Thompson. Unsubtyped. Anatum. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Heidelberg. I 4,[5],12:i:-. Infantis. Blockley. Blockley. Braenderup. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis; Thompson. Heidelberg. I 4,[5],12:i:-. Paratyphi B. Typhimurium. Typhimurium. Braenderup. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis. Enteritidis; Infantis. Heidelberg. Infantis. Infantis. Thompson. Enteritidis. Enteritidis. Enteritidis. 26271 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 Food and Nutrition Service (FNS), USDA. ACTION: Notice. AGENCY: 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 https:// 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 SUMMARY: Affected public 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 Instrument Estimated number of respondents Number of responses per respondent 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. Total annual responses Estimated total hours per response Estimated total burden ddrumheller on DSK120RN23PROD with NOTICES1 Reporting State Agencies ........................................ State Agencies ........................................ FNS 843 ........ FNS 844 ........ 56 56 6 22 336 1,232 .50 .50 168 616 Total Estimated Reporting Burden ... ........................ 56 28 1,568 0.50 784 VerDate Sep<11>2014 18:44 Apr 27, 2023 Jkt 259001 PO 00000 Frm 00023 Fmt 4703 Sfmt 9990 E:\FR\FM\28APN1.SGM 28APN1

Agencies

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

========================================================================
Notices
Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.

========================================================================

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

[[Page 26249]]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2022-0013]

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

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed determination and request for comments.

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

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

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

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

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

SUPPLEMENTARY INFORMATION:

Table of Contents

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

I. Background

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

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

[[Page 26250]]

products based on the assumption that ordinary cooking is generally
sufficient to destroy the pathogens.^{1 2} The exceptions are
Escherichia coli O157:H7 (E. coli O157:H:7) \3\ and certain non-O157
Shiga toxin-producing Escherichia coli (STEC) in raw, non-intact beef
products and intact cuts that are to be further processed into non-
intact products before being distributed for consumption. As discussed
below, these pathogens are considered adulterants in these specific raw
products because they render ``injurious to health'' what many
consumers believe to be properly cooked non-intact beef products.\4\
---------------------------------------------------------------------------

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

STEC as Adulterants

When FSIS determined that certain STEC are adulterants in non-
intact raw beef products, the Agency identified characteristics
associated with both the pathogen and the product that distinguish them
from other raw products contaminated with other pathogens.
Specifically, in 1994, when FSIS initially notified the public that raw
ground beef products contaminated with E. coli O157:H7 are adulterated
within the meaning of the FMIA, the Agency noted that exposure to E.
coli O157:H7 organisms had been linked with serious, life-threatening
human illnesses, such as hemorrhagic colitis and hemolytic uremic
syndrome (HUS).\5\ In addition, FSIS noted that only small numbers of
E. coli O157:H7 organisms may cause illness. Because of its low
infectious dose, FSIS also noted that E. coli O157:H7 can be spread
from person-to-person, as had been reported in child day-care settings.
The Agency concluded that raw ground beef products present a
significant public health risk because they are frequently consumed
after preparation, (e.g., cooking hamburger to a rare or medium rare
state) that does not destroy E. coli O157:H7 organisms that have been
introduced below the product's surface by chopping or grinding.
---------------------------------------------------------------------------

\5\ Michael R. Taylor, FSIS Administrator. September 29, 1994.
``Change and Opportunity to Improve the Safety of the Food Supply.''
Speech to American Meat Institute Annual Convention, San Francisco,
CA.
---------------------------------------------------------------------------

In 1999, FSIS published a Federal Register notice to update its
policy concerning raw beef products contaminated with E. coli O157:H7
(64 FR 2803, Jan. 19, 1999). In the notice, FSIS stated that the public
health risk presented by beef products contaminated with E. coli
O157:H7 is not limited to raw ground beef products. In the notice, FSIS
announced that ``given the low infectious dose of E. coli O157:H7
associated with foodborne disease outbreaks and the very severe
consequences of an E. coli O157:H7 infection, the Agency believes that
the status under the FMIA of beef products contaminated with E. coli
O157:H7 must depend on whether there is adequate assurance that
subsequent handling of the product will result in food that is not
contaminated when consumed'' (64 FR 2803). The Agency also explained
that ``in evaluating beef products contaminated with E. coli O157:H7,
intact cuts of muscle that are to be distributed for consumption as
intact cuts should be distinguished from non-intact products as well as
from intact cuts of muscle that are to be further processed into non-
intact product prior to distribution for consumption'' (64 FR 2803,
2804). Intact beef cuts of muscle include steaks, roasts, and other
intact cuts in which the meat interior remains protected from pathogens
migrating below the exterior surface and are not considered adulterated
if the outer surface is contaminated with STEC. FSIS stated that, with
the exception of intact cuts of muscle that are to be distributed for
consumption as intact cuts, an E. coli O157:H7-contaminated beef
product must not be distributed until it has been processed into a RTE
product. FSIS, therefore, deemed E. coli O157:H7 as an adulterant of
non-intact raw beef products and intact cuts that are to be further
processed into non-intact raw products before being distributed for
consumption.
In September 2011, FSIS determined that six additional STEC
serogroups (O26, O45, O103, O111, O121, and O145) are also adulterants
of raw non-intact beef products and product components used to
manufacture these products (76 FR 58157, Sept. 20, 2011). In announcing
this determination, the Agency explained that while over 50 STEC
serogroups have been associated with human illness, U.S. Centers for
Disease Control and Prevention (CDC) data shows that over 70 to 83
percent of confirmed, serogrouped, non-O157 STEC illnesses are caused
by these six STEC serogroups (76 FR 58157, 58158). Available data at
that time, including information from outbreaks and human illnesses,
showed that, like E. coli O157:H7, these six STEC were associated with
serious illnesses and that they have a relatively low infectious dose.
There is also evidence that these strains have very similar
characteristics to E. coli O157:H7 strains in that they too can survive
ordinary consumer cooking practices for raw, non-intact beef products.
Thus, FSIS determined that raw, non-intact beef products and intact
cuts to be further processed into non-intact products that are
contaminated with E. coli O157:H7 and pathogenic STEC O26, O45, O103,
O111, O121, and O145 are adulterated under the FMIA because they
contain a poisonous or deleterious substance that may render them
injurious to health (21 U.S.C. 601(m)(1)) (76 FR 31975). The Agency
also determined that raw, non-intact beef products that are
contaminated with these pathogens are unhealthful and unwholesome (21
U.S.C. 601(m)(3)) (76 FR 31975).

Petitions To Declare Certain Salmonella Serotypes as Adulterants

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

[[Page 26251]]

2011 petition without prejudice on July 31, 2014. In its response, FSIS
explained that the data available at that time ``did not support giving
the four strains of ABR Salmonella identified in the petition a
different status as an adulterant in raw ground beef and raw ground
poultry than Salmonella strains that are susceptible to antibiotics.''
\7\ The response stated that additional data on the characteristics of
ABR Salmonella are needed to determine whether certain strains could
qualify as adulterants under the FMIA and PPIA. The response also noted
that because the Agency's denial was without prejudice, the petitioner
was not precluded from submitting a revised petition that includes
additional information to support the requested action.
---------------------------------------------------------------------------

\6\ CSPI petition #11-06 (May 25, 2011), ``Petition for an
Interpretive Rule Declaring Specific Strains of Antibiotic Resistant
Salmonella to be Adulterants Withing the Meaning or 21 U.S.C.
601(m)(1) and (2)(a) and 21 U.S.C. 453(g)(1) and (2)(a).'' FSIS
final response July 31, 2014.
\7\ FSIS final response to petition #11-06, p. 1.
---------------------------------------------------------------------------

The CSPI 2014 petition was a refiling of the 2011 petition and
asked that FSIS declare certain strains of ABR Salmonella as
adulterants in all meat and poultry products based on evidence attained
since 2011 that, according to the petition, demonstrates both ground
and intact poultry products are associated with outbreaks from ABR
Salmonella.\8\ Based on the data available at the time, FSIS denied the
2014 petition without prejudice on February 7, 2018. In its response to
the petition, the Agency concluded that, with respect to its status as
an adulterant, ``Salmonella does not appear to present the same issues
as STEC, regardless of whether it is resistant or susceptible to
antibiotics.'' \9\ The Agency noted that the consumer studies submitted
in support of the petitions did not demonstrate that the study
participants had expressed a specific preference or intent to prepare
or consume a meat or poultry product in a manner that is not properly
cooked and did not describe specific characteristics of a meat or
poultry product that consumers might mistakenly associate with proper
cooking, such as a rare or medium rare hamburger. Thus, based on the
consumer studies and other information on Salmonella available at that
time, FSIS determined that it ``had no basis to conclude that either
ABR-Salmonella or non-ABR Salmonella would render injurious to health
what consumers consider to be properly cooked meat or poultry.'' \10\
---------------------------------------------------------------------------

\8\ CSPI petition #14-01 (October 1, 2014), ``Request for an
Interpretive Rule Declaring Certain Antibiotic-Resistant Strains of
Salmonella to be Adulterants'' and FSIS final response (February 7,
2018) at: https://www.fsis.usda.gov/federal-register/petitions/request-interpretive-rule-declaring-certain-antibiotic-resistant-strains.
\9\ FSIS final response to petition #14-06, p. 6. Available at:
https://www.fsis.usda.gov/federal-register/petitions/request-interpretive-rule-declaring-certain-antibiotic-resistant-strains.
\10\ FSIS final response to petition #14-06, p. 7. Available at:
https://www.fsis.usda.gov/federal-register/petitions/request-interpretive-rule-declaring-certain-antibiotic-resistant-strains.
---------------------------------------------------------------------------

FSIS also considered whether certain Salmonella serotypes should be
considered as adulterants in all meat and poultry products in response
to a petition submitted by Marler Clark LLP on behalf of several
individuals and consumer advocacy organizations in January 2020.\11\
The petition asked FSIS to declare 31 Salmonella serotypes that have
been associated with foodborne illness outbreaks to be adulterants of
all meat and poultry products subject to the FMIA and the PPIA.
---------------------------------------------------------------------------

\11\ Marler Clark LLP petition #20-01 ``Petition for an
Interpretive Rule Declaring `Outbreak' Serotypes of Salmonella
enteritica subspecies to be Adulterants'' dated January 19, 2020.
Available at: https://www.fsis.usda.gov/policy/petitions/petition-interpretive-rule-related-certain-salmonella-serotypes.
---------------------------------------------------------------------------

In its response to the petition, FSIS explained that while the
Agency agrees that it needs to rethink its existing Salmonella strategy
to reduce human illnesses associated with poultry, it does not believe
that there is sufficient data available at this time to support the
sweeping actions requested in the petition.\12\ The response noted
that, as announced in October 2021,\13\ FSIS is in the process of re-
evaluating its approach to controlling Salmonella in poultry and is
considering many of the points and arguments made in the petition as
part of its re-evaluation. The response also noted that while FSIS has
traditionally viewed Salmonella as ``naturally occurring'' in food
animals, the Agency is reassessing this interpretation as part of its
Salmonella in poultry initiative and considering whether Salmonella
should be considered an adulterant in any poultry products. The
response stated that in this consideration, FSIS is relying on the
factors it identified when the Agency declared certain STEC strains to
be adulterants in raw non-intact beef products and intact source
materials for raw ground beef.
---------------------------------------------------------------------------

\12\ FSIS Final Response to Petition #20-01, May 31, 2022.
Available at: https://www.fsis.usda.gov/policy/petitions/petition-interpretive-rule-related-certain-salmonella-serotypes.
\13\ United States Department of Agriculture. (October 19,
2021). USDA Launches New Effort to Reduce Salmonella Illness Linked
to Poultry. https://www.usda.gov/media/press-releases/2021/10/19/usda-launches-new-effort-reduce-salmonella-illnesses-linked-poultry;
see also Food Safety and Inspection Service. (December 2, 2021).
Pilot Projects: Salmonella Control Strategies. https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry/pilot.
---------------------------------------------------------------------------

On January 25, 2021, CSPI and other consumer advocacy organizations
and individuals petitioned FSIS to establish enforceable standards
targeting Salmonella types of greatest public health concern and all
Campylobacter in poultry, and to require supply chain controls.\14\
With respect to the request to establish enforceable performance
standard, the petition asserts that FSIS should focus specifically on
the types of Salmonella of greatest public health concern and declare
the most virulent Salmonella strains to be adulterants in raw poultry
products. The petition also requests that FSIS employ enforceable
quantitative thresholds to ensure that any Salmonella or Campylobacter
that is permitted on poultry products is maintained at levels low
enough to be less likely to cause human illness. The petition asserts
that 21 U.S.C. 453(g)(1) authorizes FSIS to deem poultry products that
contain virulent Salmonella strains and that contain pathogens levels
above a set threshold to be adulterated under the PPIA.
---------------------------------------------------------------------------

\14\ CSPI petition #21-01, ``Petition to Establish Enforceable
Standards Targeting Salmonella Types of Greatest Public Health
Concern while Reducing all Salmonella and Campylobacter in Poultry,
and to Require Supply Chain Controls'' (January 25, 2021) at:
https://www.fsis.usda.gov/policy/petitions/petition-submitted-center-science-public-interest.
---------------------------------------------------------------------------

FSIS is currently reviewing the 2021 CSPI petition and supporting
information. As noted above, FSIS is in the process of reevaluating its
approach to controlling Salmonella in poultry. Because the actions
requested in the 2021 CSPI petition are directly related to this
effort, FSIS is considering the petition and supporting information as
part of its reevaluation.

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

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

[[Page 26252]]

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

II. NRTE Breaded Stuffed Chicken Products

NRTE breaded stuffed chicken products contain raw, comminuted
chicken breast meat, trim, or whole chicken breast meat, but the
finished product is heat-treated only to set the batter or breading on
the exterior of the product, which may impart an RTE appearance.\15\
The product typically is stuffed with ingredients, such as a raw
vegetable, butter, cheese or meat such as ham, and is typically cooked
by household consumers from a frozen state. NRTE breaded stuffed
chicken products do not include other types of stuffed products that
are not breaded, such as turducken or whole stuffed chickens. NRTE
breaded products that are not also stuffed, such as chicken nuggets and
other par-fried products are not included in this product type. Only
NRTE products that are both breaded and stuffed are the subject of this
policy.
---------------------------------------------------------------------------

\15\ FSIS Directive 5300.1, Revision 1. Managing the
Establishment Profile in the Public Health Information System (Oct
19, 2016). See attachment 2 ``NRTE Stuffed Chicken Products that
appear RTE.'' Available at: https://www.fsis.usda.gov/policy/fsis-directives/5300.1.
---------------------------------------------------------------------------

NRTE breaded stuffed chicken products contain raw poultry and thus
may contain pathogens, such as Salmonella. However, because the product
may appear fully cooked, some consumers may only reheat the product for
aesthetic or palatability purposes rather than subject it to cooking
sufficient to kill pathogenic bacteria. NRTE breaded stuffed chicken
products are also typically cooked from a frozen state, which increases
the risk that they will not reach an internal temperature needed to
destroy Salmonella organisms that may be in the product. While NRTE
chicken nuggets and other par-fried breaded products that are not
stuffed may also have a cooked appearance, the focus of this document
is on NRTE breaded stuffed chicken products because these stuffed
products are thicker in diameter and have a different composition than
other par-fried breaded products, which can make effective cooking of
NRTE breaded stuffed chicken products more challenging. In addition, it
may be difficult for a consumer to determine an accurate internal
temperature of these products because they contain multiple ingredients
that may cook at different rates. FSIS has recommended in the past that
consumers check the temperature at multiple locations throughout the
product, but this is not always practical or accurate.\16\ In addition,
NRTE breaded stuffed chicken products have been associated with a
number of Salmonella illness outbreaks in the United States.
---------------------------------------------------------------------------

\16\ Smith, K.E., Medus, C., Meyer, S.D., Boxrud, J.D., Leano,
F., Hedburg, C., Elfering, K., Braymen, C., Bender, J.B., Danila,
R.N. 2008. Outbreaks of Salmonellosis in Minnesota (1998 through
2006) Associated with Frozen, Microwaveable, Breaded Stuffed Chicken
Products. Journal of Food Protection. 71(10): 2153-2160.
---------------------------------------------------------------------------

Before 2006, many NRTE breaded stuffed chicken products were
marketed as a microwaveable product, and the labeling on the product
packaging included instructions for cooking the products in both a
microwave and conventional oven. However, as discussed below,
information from documented Salmonella illness outbreaks associated
with NRTE breaded stuffed chicken products from 1998 through 2006
showed that, based on the product's labeling, appearance, and frozen
state, most case patients that became ill after consuming these
products thought that the product was pre-cooked, and therefore, did
not cook it to an internal temperature necessary to destroy pathogens.
In response, industry producers have made numerous changes to the
labeling of NRTE breaded stuffed chicken products over time to inform
consumers that these products are raw and to provide instructions on
how to prepare them safely. In addition, industry no longer markets
NRTE breaded stuffed chicken products as microwavable products because
cooking these products in a microwave oven decreases the chances that
they will reach an internal temperature needed to destroy Salmonella.
From 1998 to 2021, FSIS and public health partners have investigated 14
Salmonella illness outbreaks associated with consumption of NRTE
breaded stuffed chicken products, which are summarized below and listed
in Table 1. An FSIS analysis of all chicken associated outbreaks the
Agency identified in the CDC National Outbreak Reporting System (NORS)
\17\ or in the scientific literature from 1998-2020 found that although
NRTE breaded stuffed chicken products account for less than 0.15
percent of the total domestic chicken supply (in 2021, 53.9 million
pounds of NRTE breaded stuffed chicken were produced compared to 45.4
billion pounds of raw chicken products overall), outbreaks linked to
these products represented approximately five percent of all chicken-
associated outbreaks in the United States during this time. (See
Appendix A for the list of Salmonella outbreak investigations
associated with all chicken products from 1998-2020).
---------------------------------------------------------------------------

\17\ CDC National Outbreak Reporting System available at:
https://www.cdc.gov/nors/.
---------------------------------------------------------------------------

Salmonella Illness Outbreak Investigations Associated With NRTE Breaded
Stuffed Chicken Products 1998-2016 and FSIS and Industry Response

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

\18\ Smith K, Medus C, Meyer S. et al. Outbreaks of
Salmonellosis in Minnesota (1998 through 2006) Associated with
frozen, microwavable, breaded, stuffed chicken products (2008).
Journal of Food Protection, 71(10), 2153-2160.
\19\ Smith, K. et al. (2008).
---------------------------------------------------------------------------

In the second outbreak in early 2005, four Salmonella Heidelberg
human illnesses were associated with raw, frozen, stuffed, breaded,
pre-browned, and microwaveable chicken products.\20\

[[Page 26253]]

One elderly case patient was hospitalized for 4 days. The duration of
the outbreak was three months. A separate published report noted that
additional Salmonella cases associated with similar products were also
reported in Michigan.\21\ In response to the outbreak, FSIS issued a
public health alert (PHA) to remind consumers that frozen meat and
poultry products must be fully cooked before they are consumed. In
addition, the manufacturer modified the labels of the products to
include the word ``uncooked'' and verified the cooking instructions.
---------------------------------------------------------------------------

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

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

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

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

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

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

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

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

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

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

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

[[Page 26254]]

outbreaks associated with NRTE breaded stuffed chicken products. From
February to April 2008, the Minnesota Department of Health (MDH)
identified seven Salmonella Enteritidis illnesses associated with
frozen, pre-browned breaded stuffed chicken products.\30\ Five of the
seven case patients reported cooking the product in the microwave, even
though the cooking instructions did not include microwave preparation
and recommended against that method of cooking. In response, FSIS
issued a PHA in March 2008 to remind consumers of the importance of
following package instructions for NRTE breaded stuffed chicken
products and to emphasize that it is important to cook these products
in a conventional oven.\31\ The PHA identified the establishment that
had produced the products associated with the illnesses, and FSIS
conducted a Food Safety Assessment (FSA) \32\ at the establishment.
---------------------------------------------------------------------------

\30\ Minnesota Department of Health Annual Summary of Disease
Activity: Disease Control Newsletter. Salmonella 2008 at: https://www.health.state.mn.us/diseases/reportable/dcn/sum08/salmonellosis.html.
\31\ FSIS Public Health Alert, March 29, 2008.
\32\ The purpose of an FSA is to conduct a risk-based, targeted
review of establishment food safety systems to verify that the
establishment is able to produce safe and wholesome meat or poultry
products in accordance with FSIS statutory and regulatory
requirements (https://www.fsis.usda.gov/policy/fsis-directives/5100.1).
---------------------------------------------------------------------------

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

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

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

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

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

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

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

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

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

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

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

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

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

[[Page 26255]]

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

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

2015-2016 outbreak investigations. In 2015 and 2016, FSIS and
public health partners investigated three Salmonella outbreaks
associated with NRTE breaded stuffed chicken products. The MDH,
Minnesota Department of Agriculture, CDC, and FSIS investigated two
separate Salmonella Enteritidis outbreaks associated with NRTE breaded
stuffed chicken products produced by different establishments from June
2015 through October 2015.^{44 45} One of the outbreaks
included five cases from Minnesota with illness onset dates from May 9,
2015, through July 22, 2015.\46\ Two of the case patients were
hospitalized. All case patients reported consuming various NRTE breaded
stuffed chicken products the week before illness onset. All products
were produced at the same establishment. In follow-up interviews, two
case patients stated that they were aware that the product was raw,
three stated that they cooked the product in a conventional oven as
instructed on the label, one reported that they used a convection oven/
microwave and used a thermometer to confirm that the product reached an
internal temperature of 165 [deg]F, and one case patient stated that
they were not aware that the product was raw and cooked it in a
microwave.
---------------------------------------------------------------------------

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

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

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

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

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

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

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

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

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

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

[[Page 26256]]

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

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

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

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

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

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

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

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

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

[[Page 26257]]

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

Consumer Behavior Research

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

[[Page 26258]]

which appliances they use to prepare these products. Respondents could
choose more than one appliance. Of the 2,546 panel members that
reported preparing NRTE breaded stuffed chicken products, approximately
80 percent reported using an oven as one of the cooking appliances,
while 54 percent reported that they prepared these products using
appliances other than or in addition to ovens. Although the labeling of
NRTE breaded stuffed chicken products typically includes instructions
to cook the product in an oven and warns consumers not to cook them in
a microwave, approximately 30 percent of the respondents who reported
preparing NRTE breaded stuffed chicken products reported using air
fryers, 20 percent reported using microwaves, approximately 14 percent
reported using toaster ovens, and approximately 4 percent reported
using another appliance. The study found that respondents with lower
incomes and who live in mobile types of homes reported lower oven use
and higher microwave use.
---------------------------------------------------------------------------

\66\ Marshall, K.E., Canning, M., Ablan, M., Crawford T.N.,
Robyn, M. Appliances Used by Consumers to Prepare Frozen Stuffed
Chicken Products-United States, May-July 2022. Morb Mortal Wkly Rep
Dec 2,2022; 71(48);1511-1516. Available at: https://dx.doi.org/10.15585/mmwr.mm7148a2.
---------------------------------------------------------------------------

The study noted that current measures to prevent Salmonella
infections linked to contaminated NRTE breaded stuffed chicken products
primarily rely on consumers' ability to identify that they are raw,
follow and adequately cook the products according to validated cooking
instructions, and to verify the product's internal temperature using a
food thermometer. The researchers stated that the survey findings
highlight some possible challenges consumers may face preparing NRTE
breaded stuffed chicken products safely and the need for additional
action. The study suggests that, given the percentage of respondents
who reported using an appliance other than an oven to prepare NRTE
breaded stuffed chicken products, and socioeconomic characteristics of
respondents with lower oven usage, e.g., oven use was lower among
respondents with household income <$25,000 (68.9%), and who lived in
mobile homes or other portable types of homes (66.5%), companies that
produce these products could consider implementing interventions that
rely less on labeling and consumer preparation practices to ensure that
these products are safe when consumed. The study noted that persons who
live in mobile or other portable types of homes might have less or
insufficient space for a conventional oven and that appliances like
microwaves are small, often portable, and cost less to own and operate
than an oven. According to the study, these findings suggest that
economic and other factors might influence some groups' access to
recommended cooking appliances.

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

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

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

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

[[Page 26259]]

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

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

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

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

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

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

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

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

[[Page 26260]]

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

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

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

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

[[Page 26261]]

for further processing.^{83 84} Salmonella-contaminated
equipment used to incorporate the stuffed ingredients into the chicken
component of NRTE breaded stuffed chicken products may also contribute
to Salmonella contamination in these products. Thus, because Salmonella
may be added to previously uncontaminated chicken parts and comminuted
chicken during processing, and because the chicken component of NRTE
breaded stuffed chicken products is made from further processed poultry
parts or comminuted poultry, FSIS has tentatively concluded that
Salmonella is an ``added substance'' when present in these specific
products.
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\79\ Kim J-W and Slavik M.F. 1996. Cetylpyridinium Chloride
(CPC) treatment on poultry skin to reduce attached Salmonella. J.
Food Prot. 59: 322-326.
\80\ Wu D., Alali W.Q., Harrison M.A., and Hofacre C.L. 2014.
Prevalence of Salmonella in neck skin and bone of chickens. J Food
Prot. 77(7): 1193-1197.
\81\ FSIS Guidance for Controlling Salmonella in Poultry (June
2021) pp. 59-60. Available at: https://www.fsis.usda.gov/guidelines/2021-0005.
\82\ FSIS Guidance for Controlling Salmonella in Poultry (June
2021) pp. 65-66, Table 4 FSIS exploratory sampling test results, raw
comminuted chicken by source material composition (6/1/13-6/30/15,
2,688 samples. Available at: https://www.fsis.usda.gov/guidelines/2021-0005.
\83\ FSIS Guidance for Controlling Salmonella in Poultry (June
2021) pp. 59. Available at: https://www.fsis.usda.gov/guidelines/2021-0005.
\84\ Codex Guideline for the Control of Campylobacter and
Salmonella in Chicken Meat at https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B78-2011%252FCXG_078e.pdf.
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The Adulteration Standard for NRTE Breaded Stuffed Chicken Products

As noted above, a poultry product that bears or contains any added
poisonous or deleterious substance which may render it injurious to
health or that bears or contains an inherent substance in sufficient
quantity to ordinarily render it injurious to health is adulterated
under the PPIA (21 U.S.C. 453(g)(1)). A poultry product can also be
found to be adulterated if it is ``unsound, unhealthful, unwholesome,
or otherwise unfit for human food'' (21 U.S.C. 453(g)(3)).
Consistent with its approach used to determine the status of
certain STEC in raw non-intact beef products and intact cuts to be
further processed into non-intact products, to assess the status of
Salmonella in NRTE breaded stuffed chicken products under the PPIA,
FSIS has evaluated the available information on Salmonella serotypes
associated with human illnesses, the Salmonella infectious dose, the
severity of human illnesses caused by Salmonella, and consumer
preparation practices associated with NRTE breaded stuffed chicken
products as documented in outbreak investigations associated with these
products and as described in the consumer behavior research studies
discussed above. Based on this evaluation, FSIS is proposing to declare
that NRTE breaded stuffed chicken products contaminated with Salmonella
at levels of 1 CFU/gram or higher are adulterated within the meaning of
21 U.S.C. 453(g)(1) and 21 U.S.C. 453(g)(3) of the PPIA.
Because FSIS has tentatively concluded that Salmonella is an added
substance in NRTE breaded stuffed chicken products, the Agency has
tentatively concluded that these products are adulterated when they
contain Salmonella at levels of 1 CFU per gram or higher because
Salmonella at these levels ``may render'' NRTE breaded stuffed chicken
products injurious to health (21 U.S.C. 453(g)(1)).\85\ Moreover, FSIS
is proposing to declare that NRTE breaded stuffed chicken products that
are contaminated with Salmonella at levels of 1 CFU per gram or above
are adulterated within the meaning of 21 U.S.C. 453(g)(3) because when
they contain Salmonella at these levels, NRTE breaded stuffed chicken
products present a sufficiently serious risk of causing human
Salmonella illnesses such as to make them unhealthful, unwholesome, or
otherwise unfit for human food. The basis for this proposed
determination is discussed below.
---------------------------------------------------------------------------

\85\ The adulteration definition in 21 U.S.C. 453(g)(1) includes
two separate standards for determining whether a product is
adulterated. Under 21 U.S.C. 453(g)(1), if a substance is an ``added
substance'' the product is adulterated if the substance ``may
render'' the product injurious to health. If the substance is not
added, the product is adulterated ``if the quantity of such
substance in or on'' the product ``ordinarily'' renders it injurious
to health. As discussed in this document, FSIS has tentatively
concluded that when present in NRTE breaded stuffed chicken
products, Salmonella at 1 CFU per gram or higher meets the
definition of an ``added substance'' that ``may render'' these
products injurious to health. Although the ``may render'' standard
is the primary basis for FSIS' tentative determination that the
product is adulterated, FSIS also believes that NRTE breaded stuffed
chicken products that contain Salmonella at 1 CFU per gram or higher
meet the more stringent ``ordinarily injurious'' standard for
substances that are not added because ordinary consumer handling and
preparation, as reported in outbreak investigations and consumer
research, may not reduce Salmonella to levels that do not result in
illness and may also contribute to cross-contamination when these
products are prepared in the home.
---------------------------------------------------------------------------

Pathogen serogroups or types associated with human illness. With
respect to specific Salmonella serotypes, the Salmonella outbreaks
associated with NRTE breaded stuffed chicken products investigated by
FSIS and public health partners have been associated with the serotypes
Typhimurium, Heidelberg, I 4,[5], 12:i:-, and Enteritidis and tend to
reflect the outbreak serotypes for raw chicken products in general. All
outbreaks documented after 2009 have involved Salmonella Enteritidis.
Additionally, from 2017 to 2021, FSIS and public health partners
investigated 13 Salmonella outbreaks potentially associated with all
raw chicken products.\86\ Serotypes Typhimurium, Enteritidis, Blockley,
and Infantis account for 92 percent of the outbreak related illnesses.
These 4 serotypes account for 77.4 percent of 1,946 illnesses reported
in the National Outbreak Reporting System due to Salmonella from
chicken during the years 2015-2019 (61 outbreaks).\87\ Approximately
2,500 Salmonella serotypes have been identified,\88\ though not all
serotypes have been isolated from chicken. Almost all strains of
Salmonella are pathogenic as they have the ability to invade, replicate
and survive in human host cells, resulting in potentially fatal
disease,\89\ though not all are equally likely to cause illness.
Additionally, according to the CDC, reported cases from outbreaks only
represent a fraction of actual cases.\90\ Thus, because the reported
outbreaks represent a small portion of Salmonella illnesses, the
serotypes that have been found to be associated with Salmonella
outbreaks do not capture all serotypes that are causing illnesses.
---------------------------------------------------------------------------

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

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

[[Page 26262]]

variations in gene sequence and expression. In an August 2018 report,
the NACMCF was unable to find evidence in the literature for any
determinant that correlated with high virulence in human foodborne
disease.\91\ The NACMCF noted that a few Salmonella serotypes are
consistently associated with the greatest incidence of human disease.
However, this disparity among serotypes may be related to survival in
animal hosts or during food harvesting and processing rather than
serotype-specific differences in human virulence.
---------------------------------------------------------------------------

\91\ NACMCF (2019). Response to Questions Posed by the Food
Safety and Inspection Service Regarding Salmonella Control
Strategies in Poultry. Journal of Food Protection 82(4): 645-668.
---------------------------------------------------------------------------

FSIS seeks to better understand Salmonella characteristics,
including virulence, and actively engages in and encourages research in
this area. In October 2021, FSIS launched a new effort aimed at
developing a stronger and more comprehensive framework for reducing
Salmonella illnesses associated with poultry products.\92\ As part of
this initiative, FSIS will leverage USDA's strong research \93\
capabilities and strengthen its partnership with the USDA Research
Education and Economics \94\ mission area to address data gaps and
develop new laboratory methods to guide future Salmonella policy. FSIS
is also exploring more efficient methods to enumerate pathogens in
samples, detect virulence factors in pathogens, and investigate new
pathogen characterization methods. As science and laboratory
technologies advance, FSIS will continue to use the most innovative and
sensitive methods available to protect public health.
---------------------------------------------------------------------------

\92\ USDA Launches New Effort to Reduce Salmonella Linked to
Poultry (October 19, 2021) at: https://www.usda.gov/media/press-releases/2021/10/19/usda-launches-new-effort-reduce-salmonella-illnesses-linked-poultry.
\93\ FSIS Food Safety Research Priorities and Studies, available
at https://www.fsis.usda.gov/science-data/research-
priorities#:~:text=FSIS%20Data%20Gaps%20%20%20%20Study%20Title,may%20
survi%20...%20%209%20more%20rows%20?msclkid=f7030eaea6c411ec9e91f63d1
dde98ff.
\94\ USDA Research, Education, and Economics website, available
at: https://www.ree.usda.gov/
#:~:text=The%20Research%2C%20Education%2C%20and%20Economics%20%28REE%
29%20mission%20area,and%20youth%20through%20integrated%20research%2C%
20analysis%2C%20and%20education.?msclkid=261bd671a6c411eca6c1c87daaae
90cd.
---------------------------------------------------------------------------

Therefore, after considering the current state of the science and
laboratory technology, to address the significant public health risk
associated with NRTE breaded stuffed chicken products contaminated with
Salmonella, FSIS is proposing to declare, at certain levels, all
Salmonella as adulterants in NRTE breaded stuffed chicken products at
this time. Although certain Salmonella serotypes have been associated
with illnesses identified in outbreak investigations associated with
NRTE breaded stuffed chicken products, as discussed above, the basis
for Salmonella virulence is not fully understood, all Salmonella
serotypes have the potential to cause illness, and, as noted in the
2018 NACMCF report, the disparity among serotypes may be related to
factors other than serotype-specific differences in human virulence. In
addition, FSIS' current laboratory methods typically require
approximately 14 days from sample collection for results to be reported
for Salmonella serotypes. Therefore, FSIS is tentatively declaring all
Salmonella at certain levels as an adulterant in NRTE breaded stuffed
chicken products. As noted above, FSIS is actively seeking research to
address data gaps and develop more efficient laboratory methods to,
among other things, enumerate and characterize pathogens and detect
virulence factors in pathogens. FSIS will continue to evaluate and, if
necessary, refine its proposed determination on the status of
Salmonella as an adulterant in NRTE breaded stuffed chicken products as
advances in science and technology related to pathogen levels,
serotypes, and infectious dose become available. FSIS will consider
public comments before issuing a final determination of Salmonella as
an adulterant in NRTE breaded stuff chicken products.
Infectious dose. Foodborne outbreaks are extraordinary events where
conditions combine to result in illness among a group of people. It
could be that a highly sensitive group of people, e.g.,
immunosuppressed, consumed contaminated product. It could be that a
unique and significantly virulent strain is present in the food. It
could be the result of a process failure where a high number of
infectious organisms are present in the food. Outbreaks also may occur
due to exposure of a large number of consumers to contaminated product.
A combination of those four factors--agent virulence, dose, consumer
susceptibility, and the extent of exposure--elevates the potential for
foodborne outbreaks.
In assessing the status of certain STEC as adulterants in non-
intact raw beef products and intact cuts to be further processed into
non-intact products, FSIS considered data that indicates that the
infectious dose for these specific serogroups is relatively low.
Although Salmonella data are limited, international and domestic
outbreak investigations associated with a variety of food products have
been used to estimate the relationship between the number of organisms
consumed and the probability of illness. Five Salmonella foodborne
outbreaks have shown that Salmonella can cause illness from exposure of
10 or fewer organisms per person.\95\ Additionally, several outbreaks
from a range of Salmonella serotypes in various food products have
shown that exposure from 11 to 420 organisms per person can result in
illness.\96\ Thus, in these published studies, the infectious dose
ranged from 1 to 420 Salmonella organisms per person. Using a dose-
response model approach utilizing outbreak data, and accounting for
variation among

[[Page 26263]]

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

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

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

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

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

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

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

\102\ Scallan, et al., 2011.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

\103\ Scallan, et al. 2011; Mead, P.S., et al., Food-related
illnesses and deaths in the United States. Emerging Infect Dis,
Oct1999. 5(5) p. 607-625.
---------------------------------------------------------------------------

In addition, because NRTE breaded stuffed chicken products are
typically stored in the freezer and consumed over time, Salmonella
illness outbreaks associated with these products tend to persist for
several months, even when implicated products represent a few days of
production. Thus, the long, recurring history and ongoing nature of
Salmonella illness outbreaks associated with NRTE breaded stuffed
chicken products raise significant concerns about the impact on human
health of Salmonella contamination in these products.
Consumer cooking practices. In addition to their relatively low
infectious dose and potential to cause severe illness, certain STEC are
considered as adulterants in raw non-intact beef product because there
is evidence to show that these strains can survive what many consumers
consider to be proper cooking of these products. Information from the
outbreak investigations associated with NRTE

[[Page 26264]]

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

IV. Proposed Policy Implementation

HACCP Reassessment

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

Proposed Implementation and Status of Laboratory Methods

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

[[Page 26265]]

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

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

FSIS estimates that negative results would routinely be available
within 48 hours of shipment of the samples to the laboratory, assuming
overnight sample transit coupled with a 24-hour sample enrichment and
screening at the laboratory. For samples that screen positive, an
additional 2 to 4 days may be necessary for a confirmed positive or
negative result. Enumeration is run concurrently with confirmatory
testing and would be reported with the confirmed positive result.
Salmonella serotypes, WGS, and AMR profile would require at least 14
days for result reporting. These timeframes and methods may change as
FSIS incorporates new laboratory technologies into its sampling
verification program.\106\
---------------------------------------------------------------------------

\106\ For example, on July 8, 2022, FSIS announced that it had
awarded a contract to bioM[eacute]rieux to incorporate its non-
enrichment quantification system for Salmonella, `GENE-
UP^TM QUANT Salmonella,' into the Agency's laboratory
system. The Agency evaluated commercially available quantification
systems and determined that this technology is the most appropriate
for use in the high throughput FSIS laboratory environment. FSIS
stated that in the future, the Agency would announce when the method
is available and when it will be implemented in all three FSIS food
testing laboratories. FSIS also stated that it plans to extend
pathogen quantification technology to sample types other than raw
poultry rinses in the future (see FSIS Constituent Update, Jul 8,
2022, FSIS to include Salmonella Quantification in Raw Poultry Rinse
Samples. Available at: https://www.fsis.usda.gov/news-events/news-
press-releases/constituent-update-july-8-
2022#:~:text=Salmonella%20quantification%20is%20a%20significant%20ste
p%20in%20FSIS%E2%80%99,regulatory%20sample%2C%20not%20solely%20its%20
presence%20or%20absence.
---------------------------------------------------------------------------

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

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

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

[[Page 26266]]

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

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

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

Sampled Lot

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

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

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

State Programs and Foreign Government Programs

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

[[Page 26267]]

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

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

V. Anticipated Costs and Benefits Associated With This Proposed
Determination

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

Summary of Estimated Costs and Benefits

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

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

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

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

Potential Impact on Small Businesses

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

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

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

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

USDA Non-Discrimination Statement

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

[[Page 26268]]

Additional Public Notification

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

Paul Kiecker,
Administrator.

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

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

[[Page 26269]]

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

[[Page 26270]]

115................ CDC NORS.......... 2014 Chicken.......... chicken, grilled. Heidelberg.
116................ CDC NORS.......... 2014 Chicken.......... chicken.......... Infantis.
117................ CDC NORS.......... 2014 Chicken.......... chicken, smoked.. Thompson.
118................ CDC NORS.......... 2014 Chicken.......... sandwich, chicken Thompson.
119................ CDC NORS.......... 2015 Chicken.......... chicken, Braenderup.
rotisserie.
120................ CDC NORS.......... 2015 Chicken.......... chicken, Derby.
rotisserie.
121................ CDC NORS.......... 2015 Chicken.......... Stuffed chicken.. Enteritidis.
122................ CDC NORS.......... 2015 Chicken.......... chicken tenders.. Enteritidis.
123................ FSIS/NORS......... 2015 Chicken.......... frozen, raw, Enteritidis.
stuffed and
breaded chicken.
124................ FSIS/NORS......... 2015 Chicken.......... chicken Kiev, Enteritidis.
cordon bleu,.
125................ CDC NORS.......... 2015 Chicken.......... chicken, grilled; Enteritidis.
chicken,
blackened.
126................ CDC NORS.......... 2015 Chicken.......... chicken and Enteritidis.
waffles.
127................ CDC NORS.......... 2015 Chicken.......... chicken katsu Muenchen.
plate; korean
chicken.
128................ CDC NORS.......... 2015 Chicken.......... chicken, roasted. Unsubtyped.
129................ FSIS/NORS......... 2016 Chicken.......... Stuffed chicken.. Enteritidis.
130................ CDC NORS.......... 2016 Chicken.......... pate, chicken Enteritidis.
liver.
131................ CDC NORS.......... 2016 Chicken.......... chicken, baked... Enteritidis;
Enteritidis;
Enteritidis.
132................ CDC NORS.......... 2016 Chicken.......... chicken.......... Heidelberg.
133................ CDC NORS.......... 2016 Chicken.......... rotisserie I 4,[5],12:i:-.
chicken salad
from Costco's
Alderwood store.
134................ CDC NORS.......... 2016 Chicken.......... chicken.......... Muenchen.
135................ CDC NORS.......... 2016 Chicken.......... chicken.......... Norwich.
136................ CDC NORS.......... 2016 Chicken.......... chicken.......... Saintpaul.
137................ CDC NORS.......... 2016 Chicken.......... chicken.......... Thompson.
138................ CDC NORS.......... 2016 Chicken.......... chicken.......... Unsubtyped.
139................ CDC NORS.......... 2017 Chicken.......... sandwich, chicken Anatum.
140................ CDC NORS.......... 2017 Chicken.......... chicken.......... Enteritidis.
141................ CDC NORS.......... 2017 Chicken.......... chicken.......... Enteritidis.
142................ CDC NORS.......... 2017 Chicken.......... chicken dishes... Enteritidis.
143................ CDC NORS.......... 2017 Chicken.......... kabobs, chicken.. Enteritidis.
144................ CDC NORS.......... 2017 Chicken.......... chicken salad Enteritidis.
sandwich;
grilled chicken
salad; chicken
caesar salad.
145................ CDC NORS.......... 2017 Chicken.......... chicken.......... Enteritidis.
146................ CDC NORS.......... 2017 Chicken.......... chicken.......... Enteritidis.
147................ CDC NORS.......... 2017 Chicken.......... chicken, pulled.. Heidelberg.
148................ CDC NORS.......... 2017 Chicken.......... chicken.......... I 4,[5],12:i:-.
149................ CDC NORS.......... 2017 Chicken.......... chicken, smoked.. Infantis.
150................ CDC NORS.......... 2018 Chicken.......... chicken, raw..... Blockley.
151................ CDC NORS.......... 2018 Chicken.......... chicken.......... Blockley.
152................ CDC NORS.......... 2018 Chicken.......... chicken, grilled. Braenderup.
153................ CDC NORS.......... 2018 Chicken.......... chicken.......... Enteritidis.
154................ FSIS/NORS......... 2018 Chicken.......... raw breaded Enteritidis.
chicken.
155................ CDC NORS.......... 2018 Chicken.......... chicken, smoked.. Enteritidis.
156................ CDC NORS.......... 2018 Chicken.......... smoked chicken... Enteritidis.
157................ CDC NORS.......... 2018 Chicken.......... chicken, other... Enteritidis.
158................ CDC NORS.......... 2018 Chicken.......... chicken.......... Enteritidis;
Thompson.
159................ CDC NORS.......... 2018 Chicken.......... chicken, raw..... Heidelberg.
160................ CDC NORS.......... 2018 Chicken.......... kosher chicken... I 4,[5],12:i:-.
161................ CDC NORS.......... 2018 Chicken.......... chicken.......... Paratyphi B.
162................ CDC NORS.......... 2018 Chicken.......... chicken salad.... Typhimurium.
163................ CDC NORS.......... 2018 Chicken.......... chicken.......... Typhimurium.
164................ CDC NORS.......... 2019 Chicken.......... chicken.......... Braenderup.
165................ CDC NORS.......... 2019 Chicken.......... chicken.......... Enteritidis.
166................ CDC NORS.......... 2019 Chicken.......... chicken.......... Enteritidis.
167................ CDC NORS.......... 2019 Chicken.......... chicken.......... Enteritidis.
168................ CDC NORS.......... 2019 Chicken.......... chicken fingers.. Enteritidis.
169................ CDC NORS.......... 2019 Chicken.......... chicken.......... Enteritidis.
170................ CDC NORS.......... 2019 Chicken.......... chicken.......... Enteritidis.
171................ CDC NORS.......... 2019 Chicken.......... mechanically Enteritidis;
separated Infantis.
chicken.
172................ CDC NORS.......... 2019 Chicken.......... chicken.......... Heidelberg.
173................ CDCNORS........... 2019 Chicken.......... chicken products. Infantis.
174................ CDC NORS.......... 2019 Chicken.......... chicken.......... Infantis.
175................ CDC NORS.......... 2019 Chicken.......... chicken.......... Thompson.
176................ CDC NORS.......... 2020 Chicken.......... chicken.......... Enteritidis.
177................ CDC NORS.......... 2020 Chicken.......... chicken.......... Enteritidis.
178................ CDC NORS.......... 2020 Chicken.......... chicken.......... Enteritidis.
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[FR Doc. 2023-09043 Filed 4-27-23; 8:45 am]
BILLING CODE 3410-DM-P

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