Availability of FSIS Guideline for Controlling Salmonella in Swine Slaughter and Pork Processing Establishments, 35827-35832 [2023-11677]

Download as PDF Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices Food Safety and Inspection Service [Docket No. FSIS–2012–0026] Availability of FSIS Guideline for Controlling Salmonella in Swine Slaughter and Pork Processing Establishments Food Safety and Inspection Service (FSIS), Department of Agriculture (USDA). ACTION: Notice of availability and response to comments. AGENCY: FSIS is announcing that it has updated its guideline for pork producers on controlling Salmonella in swine from pre-harvest through slaughter. The guideline covers pre-harvest controls, including farm rearing, multi-hurdle interventions, transport, and lairage. It contains slaughter control recommendations. It also covers pork fabrication controls, including processing, packaging, and distribution controls for pork cuts and comminuted pork products. Additionally, FSIS is responding to comments on the guideline. SUMMARY: A downloadable version of the guideline is available to view and print at https://www.fsis.usda.gov/wps/ portal/fsis/topics/regulatorycompliance/guidelines. No hard copies of the guideline have been published. FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205–0495. SUPPLEMENTARY INFORMATION: ADDRESSES: ddrumheller on DSK120RN23PROD with NOTICES1 Background On January 6, 2014, FSIS announced in the Federal Register the availability of the Compliance Guideline for Controlling Salmonella in Market Hogs (79 FR 633).1 The guideline provided information on best practices that may be applied at a hog slaughter facility to prevent, eliminate, or reduce levels of Salmonella on hogs at all stages of slaughter and dressing. The guideline was designed to help hog slaughter establishments comply with the relevant regulatory requirements. When FSIS announced the availability of the guidance, the Agency also requested comments on the guidance. After review and consideration of all comments received, FSIS has made changes to and clarified certain aspects of the guideline. The revisions are 1 See: https://www.govinfo.gov/content/pkg/FR2014-01-06/pdf/2013-31488.pdf. VerDate Sep<11>2014 17:37 May 31, 2023 Jkt 259001 implement all best practices, and that each establishment must develop and implement their own best practices specific to their facility and operation. Response: FSIS added language to note that the information in this guideline is provided to help swine slaughter establishments meet regulatory requirements. FSIS also stated in the guideline that the best practices recommended do not have the Summary of Major Changes to the force and effect of law and are not Guideline meant to bind the public in any way. • FSIS changed the document title to The best practice recommendations are FSIS Guideline to Control Salmonella in based on the best scientific and practical Swine Slaughter and Pork Processing considerations and are derived from Establishments; scientific literature. This document is • FSIS removed the word intended only to clarify existing ‘‘compliance’’ from the document title regulatory requirements. Establishments and throughout the guideline to clarify should select best practice that it does not create new regulatory recommendations that work for their requirements; unique in-plant conditions, equipment, • FSIS updated the document to add and processes. Establishments may relevant, current, peer-reviewed choose to adopt different procedures scientific references related to swine than those outlined in the guideline, but slaughter, processing of pork cuts, and they would need to support that those comminuted pork products; procedures are effective in meeting • FSIS updated the pre-harvest validation requirements and to support interventions to include vaccine and decisions in the hazard analysis (9 CFR bacteriophage interventions, housing 417.4(a)(1) and 9 CFR 417.5(a)(1)). and biosecurity, and water and feed Comment: A trade association stated management; that it would be difficult for many small • FSIS included a pork products and very small establishments to outbreak history; implement many of the best practices • FSIS added a policy background outlined in the guideline because they section; may lack technical resources. The • FSIS included FSIS data collection commenter suggested that FSIS ensure and FSIS pork sampling information; that the best practices described in the • FSIS added information regarding guideline can be economically and hot shipping best practices; consistently implemented by small • FSIS added a lymph node removal establishments. best practices section; and Response: FSIS updated the guideline • FSIS removed language related to the Trichina guidance, new technologies to clarify that it is focused on small and very small establishments in support of guidance, and validation guidance the Small Business Administration’s information, because FSIS has separate initiative to provide small businesses guidance for these topics. with compliance assistance under the Comments and Responses Small Business Regulatory Enforcement Fairness Act. The guideline includes FSIS received six comments on the guidance, one from a pork producer, one science-based best practice recommendations and scientific from an individual, and four from trade citations based on what small and very associations representing the pork small establishments may have the industry. The comment summary and resources and technical ability to apply FSIS’ responses follow. in the facility. Although all General establishments can benefit from the information in the guideline, the focus Comment: Three trade associations is on the needs of small and very small stated that the guideline could be establishments to provide assistance misinterpreted as regulatory that may be otherwise unavailable. requirements. One of the trade Comment: A trade association stated associations recommended that, in the that FSIS Enforcement, Investigations final version of the guideline, FSIS and Analysis Officers (EIAOs) may not should clearly state that the best interpret or implement the guidance in practices set forth are not regulatory a consistent manner. The commenter requirements. Additionally, two of the recommended that FSIS consider trade associations suggested that FSIS developing a training program to state in the updated guideline that not address the interpretation and all establishments may be able to summarized below and are discussed in more detail in FSIS’ responses to comments. The revised guideline is available at the FSIS guidance web page at https://www.fsis.usda.gov/policy/fsisguidelines. Although comments on this guideline will no longer be accepted through www.regulations.gov, FSIS will continue to update this document, as necessary. DEPARTMENT OF AGRICULTURE 35827 PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1 ddrumheller on DSK120RN23PROD with NOTICES1 35828 Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices enforcement consistency by EIAOs for guidance documents. Response: FSIS enforces compliance with statutory and regulatory requirements; FSIS does not enforce compliance with guidance documents because they do not have the force and effect of law. However, FSIS requires EIAOs to review and be familiar with FSIS guidance to provide outreach to establishments. Comment: Three trade associations recommended removing any references to Toxoplasma gondii and Trichinella spiralis in the guideline. One trade association further recommended removing any references to Campylobacter from the guideline. The commenters argued that these pathogens do not fit into a guidance document for controlling Salmonella in market hogs. Response: FSIS removed all references to Toxoplasma gondii and Trichinella spiralis in the guideline because FSIS has a separate guidance document that addresses these pathogens. The purpose of this guidance document is to assist pork producers on controlling Salmonella in swine; therefore, FSIS also removed all references to Campylobacter. Comment: A trade association stated that FSIS should provide a clearly defined and measurable objective that works towards the goal of preventing, eliminating, or reducing levels of Salmonella on hogs. The trade organization also argued that the table with non-pathogenic indicator organism values, should not be included in the guideline. The commenter suggested that the guidance on appropriate action levels for non-pathogenic microorganisms should be removed because it did not directly relate to the control of Salmonella or any other pathogen. Response: FSIS has updated the guidance to include the recent Salmonella illness outbreaks related to pork products consumption (Table 1), and public health relevance is focused on how pork may be a vehicle for salmonellosis. In addition, the table with indicator organism criteria limits in market hogs has been removed from the guideline. All pork slaughter establishments are required to comply with the requirements of 9 CFR 310.18 for evaluation of statistical process control to minimize microbial contamination of carcasses, reduce microbial pathogens that may be present and injurious to health, control the proliferation of any remaining microorganisms, and prevent recontamination. Comment: A trade association stated that if the guideline contains best VerDate Sep<11>2014 17:37 May 31, 2023 Jkt 259001 practices related to temperatures, those temperatures should be directly related to the control of Salmonella. Response: FSIS updated the temperature recommendations to include the latest peer-reviewed research. Several temperature recommendations were removed because some small and very small establishments may not be able to implement resource-intensive equipment and procedures to maintain these temperatures. Comment: A pork producer asked FSIS to add recommendations to the guideline on how to best control Salmonella in establishments that do not utilize polishing equipment and that skin out hogs manually or with a hide puller. Response: FSIS provided best practice recommendations for commonly used steps in the slaughter process. Some establishments processes may vary. The guideline includes a recommendation that knives be sanitized frequently for establishments that use skinning to remove the hair and hide. Additionally, the recommendations for sanitation and using a multi-hurdle approach may be applicable to all establishments, including those that do not utilize polishing equipment. Comment: A pork producer asked FSIS to add recommendations to the guideline on how to best control Salmonella in establishments that split the body with the head still attached. Response: FSIS best practice recommendations for head washing and head dropping are important for all establishments, including those that split the carcass with the head still attached. FSIS updated the guideline to recommend that establishments flush the oral cavity with room-temperature water removing ingesta or other contaminants before head dropping and FSIS head inspection; maintain and sanitize head dropping equipment, as necessary, between carcasses; sanitize knives frequently and properly; and maintain and sanitize knives and equipment whenever the oralpharyngeal cavity is sectioned or there is exposure to stomach contents. References and Formatting Comment: A pork producer noted that the previous version of the guideline contained broken hyperlinks or hyperlinks that do not go to the correct location. Response: FSIS has updated all hyperlinks and references. Comment: The individual commenter asked if the information for ‘‘McMullen, 2000’’ referenced on pages 16 and 24 of the previous version of the guideline PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 should be added to the References section. Response: FSIS has updated the References section to include the correct citation information. This reference is also cited in the section titled ‘‘Pre-chill Final Rinse, Hot Rinse, and Steam Pasteurization.’’ Comment: Two trade associations suggested that FSIS update the scientific references to the most recent research from the United States. The commenters argued that most of the references are outdated and many of the studies referenced in the guideline were conducted in other countries and are not applicable in the United States. Another trade association requested that the guideline contain a reference or citation after each recommended best practice. Response: FSIS has updated all the references, removed outdated references, and included nearly 100 new peer-reviewed references to assist small and very small establishments in accessing the latest research and scientific support. The references are listed at the end of the document and are also cited in each pertinent section throughout the guideline for ease-of-use for small and very small establishments. Salmonella in Market Hogs Comment: A trade association asked if there is a link between the FSIS market hog Salmonella baseline and public health risk. Response: FSIS has updated the guideline to include the latest FSIS sampling data from the Raw Pork Products Exploratory Sampling Program.2 These updates provide a recent, thorough analysis of Salmonella prevalence in market hogs and the public health risk. Comment: A trade association asked what type of pork caused the outbreaks discussed in the guideline and if the pork was produced under FSIS inspection. Response: FSIS has updated the guidance to include the recent illness outbreaks related to pork products consumption. Table 1 lists each pork product implicated in each of the 36 illness outbreaks from 2014–2019. Retail product associated with outbreaks is typically inspected by FSIS or by State inspection programs. However, there have also been outbreaks from whole roaster hogs at church events, etc., that were from non-FSIS inspected sources. 2 See: https://www.fsis.usda.gov/science-data/ sampling-program/raw-pork-products-exploratorysampling-program#:∼:text= FSIS%20announced%20the %20launch%20of,organisms% 20in%20various%20pork%20products. E:\FR\FM\01JNN1.SGM 01JNN1 Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices Farm Rearing Comment: Two trade associations recommended adding additional best practices to the farm rearing section of the guideline on the use of vaccination in herds and on the use of non-pelleted feed. Response: FSIS updated the section on farm rearing to include housing and biosecurity measures. In addition, FSIS included sections on preharvest controls for water and feed management and preharvest vaccine and bacteriophage interventions. Comment: A trade association representing the pork industry argued that the best practice recommendations for farm rearing and transport should not be included in the guideline. The commenter argued that in most cases, establishments have little, if any, influence on such practices and that FSIS does not have jurisdiction to regulate on-farm practices. Response: FSIS recommends establishments work closely and establish communication with their livestock suppliers to identify and address on-farm controls as a means of targeting multiple areas of swine production through pre-harvest control of Salmonella coming into slaughter establishments. FSIS updated the section on live animal transport and lairage with best practice recommendations based on current scientific research because microbiological contamination in the slaughterhouse environment can start with the delivery of Salmonella-positive hogs. Control of Salmonella at the herd level is critical to prevent the spread onfarm, through hygienic processes, feed and water management, live animal transport, and lairage before hogs reach the slaughter line. Stress during transport and many on-farm factors play a significant role in spreading Salmonella. ddrumheller on DSK120RN23PROD with NOTICES1 Lairage Comment: Four trade associations commented that the best practice to disinfect lairage pens and alley ways between herds (using chlorinated alkaline detergent followed by disinfection with a quaternary ammonium solution) is overly burdensome and may not be practical for every establishment. One of these trade associations stated that there is literature to support that there are other cleaners and sanitizers that would be equally effective. Another trade group commented during ongoing production operations, constant application of cleaning solutions is not practical, cost effective, or often even possible due to VerDate Sep<11>2014 17:37 May 31, 2023 Jkt 259001 the logistics of creating space for incoming loads and moving hogs on to harvest in a continuous line. The commenter suggested that implementing such a recommendation in many establishments could lead to crowding or unnecessary agitation of the hogs. The commenter stated that it is more practical for establishments to clean and sanitize the pens and alleyways when the building and structures are empty or close to empty. Response: FSIS updated the guideline to recognize that there are numerous cleaners and sanitizers with varying application parameters and frequencies that establishments may choose to use and to recognize that those decisions should be based on the unique characteristics of an establishment’s food safety plan and available support. FSIS also included in the guidance that it is often practical to clean and sanitize pens and alleyways when they are empty. Comment: A trade association noted that the guideline recommends ensuring that hogs are washed clean (pen shower) and dry enough to preclude dripping at the time of stunning. The commenter and two other trade associations noted that this practice may not be practical for many establishments, because showering pigs in colder weather may raise animal welfare issues in addition to the possibility of ice formation. Response: In the guidance, FSIS recommends that the hogs should be dry enough to prevent dripping at the time of stunning; if they are dripping, the moisture may contribute to crosscontamination during stunning, sticking, or skinning, for those establishments that skin the carcasses instead of using a dehairing machine. FSIS updated the guidance to state that pen showers are also important measures to ensure that hogs are washed clean, when appropriate. FSIS recommends establishments consider weather conditions to determine whether it is appropriate to use pen showers. Consistent with the commenters, in the guidance, FSIS recognizes cold conditions and ice formation may create an animal welfare concern. Comment: Three trade associations asserted that the best practice recommendation for minimizing the time hogs are held in lairage had two key problems. The first is that the guideline does not specify a recommended ‘‘minimum’’ time that pigs should be held in lairage. Secondly, if pigs are not held in lairage at all, that would compromise pork quality, may result in high incidence of pale soft PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 35829 exudative conditions, and increases Salmonella contamination. Response: In the guidance, FSIS does not give a minimum time for holding hogs in lairage. Rather, FSIS recommends that establishments use a variety of preventive measures at lairage to prevent and reduce the spread of Salmonella among the herd, including minimizing the time that hogs are held in lairage and preventing overcrowding during time in lairage. Also in the guidance, FSIS encourages further study and solutions by industry in controlling and reducing the spread of Salmonella in hog slaughter facilities with particular attention to controls at lairage. Comment: A trade association recommended the best practice to use slatted or elevated floors in lairage pens to reduce waste and water accumulation. The commenter stated that, while this may be useful to those considering new construction or retrofitting, it would be cost-prohibitive for most existing facilities. The commenter further stated that many existing operations achieve acceptable results using sloped floors with proper drainage and effective cleaning and sanitizing. Response: The guidance recommends that establishments maintain lairage pens in good condition to prevent injury to animals, and that slatted, sloped, or elevated floors are important to reduce waste and water accumulation that can contribute to the spread of Salmonella. FSIS best practice recommendations do not require establishments to retrofit an existing facility. Comment: A trade association representing the pork industry noted the guideline contains a ‘‘highlight box’’ indicating that lairage is the most costeffective stage to prevent crosscontamination. The commenter stated that while lairage is currently a vulnerability for pigs to become infected, the commenter was not aware of specific scientific evidence to be able to document that it is the most costeffective stage to prevent crosscontamination. The commenter stated that an establishment’s hazard analysis should be used to make the determination of locations and costeffectiveness. Response: FSIS does state in the text of the guideline that a scientific study has shown that controls at lairage are cost-effective measures an establishment can take to prevent cross-contamination that leads to rapid infection (Van der Gaag et al., 2004). The statement has been removed from the highlight box. As stated in the guideline, establishments should select best E:\FR\FM\01JNN1.SGM 01JNN1 35830 Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices practice recommendations that work for the unique in-plant conditions, equipment, and processes. ddrumheller on DSK120RN23PROD with NOTICES1 Slaughter/Bleeding Comment: A trade association recommended that FSIS rename the ‘‘Slaughter/Bleeding’’ step and section heading to ‘‘Bleeding.’’ Response: FSIS has renamed the section heading to Bleeding. Comment: Two trade associations argued that although stick knives have tested positive for Salmonella in several studies, there is very little data to suggest that they are a ‘‘significant source’’ for Salmonella contamination. Response: FSIS recommends that knives be sanitized between each carcass. Contamination of knives, boots, the number of gut ruptures, mechanical problems, or other factors, which are common process points for handling and cross-contamination, were factors significantly associated with the prevalence of Salmonella on the carcasses in research studies (Botteldoorn et al., 2003; Letellier et al., 2009). Scalding Comment: Two of the industry groups noted that the statement references 5 °F (41 °C) should read 105 °F (41 °C). Response: FSIS has corrected typographical errors and temperatures, and the section has been updated with additional peer-reviewed references. Comment: A trade association stated that many establishments use scalding temperatures and times other than those referenced in the guideline, and this should be reflected in the guidance document. Response: The Scalding section has been updated with additional peerreviewed references, including other temperature/time combinations that have been shown to be effective in various studies. Comment: A trade association recommended that FSIS update the guideline to state that establishments should consider the type of hog, season, and equipment when determining the appropriate scalding temperature and duration. Response: FSIS updated the guidance to state that FSIS recommends considering the type of hog, season, and the equipment being used to determine and support the appropriate scalding temperature and duration. De-Hairing Comment: Two trade associations stated that the suggested best practice of cleaning and disinfecting de-hairing equipment, preferably using a clean-in VerDate Sep<11>2014 17:37 May 31, 2023 Jkt 259001 place (CIP) system, which may be applied on an ongoing basis throughout production, is not practical for this type of equipment. The industry groups argued that not all de-hairing equipment can be retrofitted with CIP systems, and many small establishments use selfcontained scalders which simultaneously de-hair the carcass. Response: FSIS updated the guideline to reflect that some establishments may find using a CIP system throughout production beneficial since it can be applied on an ongoing basis; however, FSIS recognizes in the guideline that such a system requires significant investment and appropriate equipment. As stated in the guideline, establishments should select best practice recommendations that work for the unique in-plant conditions, equipment, and processes. Comment: Two trade associations stated that the suggested best practice for removing all organic material and debris from de-hairing equipment at the end of the day is overly burdensome. The commenters stated that there are many effective ways to clean and disinfect de-hairing equipment and that specifying water pressures, types of chemicals, and contact times does not allow for flexibility. Response: FSIS removed several specific temperature and antimicrobial intervention recommendations because some small and very small establishments may not be able to implement the use of resource-intensive equipment and procedures. As stated in the guideline, FSIS recommends that intervention and control strategies be formulated based on a combination of measures that are both practical and economically feasible. Comment: Two trade associations argued that the suggested best practice to ‘‘use water between 140° to 144 °F (60 °C to 62 °C) in the de-hairing machine if the water is not chemically treated (7 ICMSF, 1998)’’ may not be practical depending on the type of equipment used. Response: FSIS included several best practice recommendations in the updated guideline, depending on the equipment type used. FSIS also recommended that establishments ensure that equipment can be cleaned and disinfected to comply with 9 CFR 416.3. As stated in the guideline, establishments should select best practice recommendations that work for the unique in-plant conditions, equipment, and processes. FSIS recommends that intervention and control strategies be formulated based on a combination of measures that are PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 both practical and economically feasible. Comment: A pork producer asked FSIS to add recommendations to the guideline on how to best control Salmonella in very small establishments that do not utilize de-hairing tanks. Response: FSIS provided best practice recommendations for commonly used steps in the slaughter process. FSIS did not update the guideline to include a separate section for establishments that do not use de-hairing tanks, but does address skinning hogs in the guidance. FSIS added a recommendation that knives be sanitized frequently for establishments that use skinning to remove the hair and hide. Additionally, the recommendations for sanitation and using a multi-hurdle approach may be applicable to all establishments, including those that do not utilize dehairing tanks. Steam/Hot Water Vacuuming Comment: Two trade associations stated that the Steam/Hot Water Vacuuming section was out of place in the document and blends information on steam vacuuming and carcass washing into a single section. The industry groups argued that it is unlikely that these interventions would be applied between the gambrelling and singeing processes. Response: FSIS has reorganized the guidance to be reflective of the steps of the process and added new sections (e.g., multi-hurdle intervention approach, pre-harvest sections, lymph node removal, shipping practices) to provide thorough best practice recommendations. In addition, FSIS has separated steam and hot water vacuum interventions from carcass rinses and washes to reflect the typical order of interventions in-plant. Singeing Best Practices Comment: A pork producer asked what best practices FSIS would recommend for small establishments to control Salmonella that do not utilize singeing cabinets. Response: FSIS provided best practice recommendations for commonly used steps in the slaughter process. Some establishments processes may vary, and some establishments may use skinning rather than scalding, dehairing, and singeing. FSIS recommends that intervention and control strategies be formulated based on a combination of measures that are both practical and economically feasible. E:\FR\FM\01JNN1.SGM 01JNN1 Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 Pre-Evisceration Carcass Rinse or Spray Comment: Two trade associations noted the suggested best practice to use water at a temperature greater than 160 °F (71.1 °C) and stated that there is support for using lower temperatures. Response: FSIS removed specific temperatures from this section of the guideline. Comment: A trade association representing the pork industry commented on the best practice that recommends that the pressure for carcass sprays not exceed 100 PSI to prevent driving contamination into the tissue. The commenter questioned what tissue the contamination would potentially be driven into. Response: FSIS has removed all reference to 100 PSI pressure spray from the guidance document. The guidance includes FSIS recommended best practices when using pre-evisceration carcass rinses and sprays. FSIS does recommend that monitoring pressure is important to prevent driving microbiological contamination into the carcass tissue. Comment: A trade association asked how the suggested best practice to minimize overspray of water or solution from the cabinet is associated with food safety. Response: FSIS has updated the guidance to reflect that establishments should minimize splash onto other carcasses to prevent potential crosscontamination. Airborne bacterial contamination has been shown to spread; therefore, FSIS recommends establishments take precautions to limit overspray and aerosolization through techniques and equipment. Comment: Two trade associations asked if the best practice recommendation of using a postevisceration rinse or spray to further reduce carcass contamination is another practice prior to a final carcass wash. The industry groups further asked if application of a final carcass wash is a regulatory requirement. Response: While a final carcass wash is not a regulatory requirement for swine slaughter establishments, FSIS recommends carcass decontamination treatments before chilling and that intervention and control strategies be formulated based on a combination of measures that are both practical and economically feasible. Studies have shown that processing procedures, such as decontamination treatments after evisceration and carcass splitting, generally result in decreased prevalence of Salmonella as the carcasses move toward the cooler. VerDate Sep<11>2014 17:37 May 31, 2023 Jkt 259001 Comment: A trade association recommended FSIS clarify recommendations concerning applying organic acids. Response: FSIS has updated the guideline to state that automated spray cabinets or handheld sprayers may be used, bearing in mind that the effectiveness of the interventions vary based on the critical operational parameters used, and appropriate scientific support is required for establishments using interventions. Bung Isolation Comment: Two trade associations requested FSIS clarify the guidance concerning bung isolation. Response: FSIS updated the guideline to state that FSIS recommends establishments bag and tie the bung before evisceration, ensuring staff pay specific attention to minimizing crosscontamination of the carcass and viscera. FSIS recommends that intervention and control strategies be formulated based on a combination of measures that are both practical and economically feasible. Pre-Chill Final Rinse/Hot Rinse/Steam Pasteurization Comment: Two trade associations recommended that FSIS provide guidance for the upper limits on water pressure for washing carcasses. Response: FSIS removed specific requirements for pressure in the guidance because the efficacy of these interventions can vary depending on the specific critical operational parameters used, including water temperature, water pressure, length of application, and chemical concentration. FSIS best practice recommendations state that establishments should implement decontamination and antimicrobial interventions using appropriate critical operational parameters. Comment: A trade association stated that there are many other antimicrobial rinses that can be applied, and that limiting the recommendation to lactic or acetic acid may imply that it is the only antimicrobial that can be used. Response: FSIS updated the guideline to include a variety of antimicrobial interventions supported by the literature. Comment: A trade association representing the pork industry suggested that FSIS mention antimicrobials in this section. The commenter noted that FSIS could provide references that include specific examples as a useful tool to assist the small and very small establishments. Response: FSIS updated the guideline to provide best practice PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 35831 recommendations, which include a variety of antimicrobial interventions supported by the literature. FSIS provided information and citations to potential antimicrobial interventions, including chlorine, trisodium phosphate, lactic acid, and acetic acid. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication online through the FSIS web page located at: https:// www.fsis.usda.gov/federal-register. 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[FR Doc. 2023–11677 Filed 5–31–23; 8:45 am] BILLING CODE 3410–DM–P DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B–35–2023] ddrumheller on DSK120RN23PROD with NOTICES1 Foreign-Trade Zone (FTZ) 207, Notification of Proposed Production Activity; LEGO Manufacturing Richmond, Inc.; (LEGO® Bricks and Toy Sets); Chester and Colonial Heights, Virginia The LEGO Group submitted a notification of proposed production activity to the FTZ Board (the Board) for the LEGO Manufacturing Richmond, Inc. facilities in Chester and Colonial Heights, Virginia, within FTZ 207. The notification conforming to the requirements of the Board’s regulations (15 CFR 400.22) was received on May 24, 2023. Pursuant to 15 CFR 400.14(b), FTZ production activity would be limited to the specific foreign-status material(s)/ component(s) and specific finished product(s) described in the submitted VerDate Sep<11>2014 17:37 May 31, 2023 Jkt 259001 notification (summarized below) and subsequently authorized by the Board. The benefits that may stem from conducting production activity under FTZ procedures are explained in the background section of the Board’s website—accessible via www.trade.gov/ ftz. The proposed finished products include LEGO® construction toy sets, and plastic, molded, interlocking bricks and various shapes and figurines (duty rate is duty-free). The proposed foreign-status materials and components include: color additives in the form of plastic granulates (synthetic organic; preparations based on titanium dioxide; ultramarine; inorganic mixtures or combinations); decoration inks; ink diluents; plastic resins; self-adhesive plastic rolls; auto-adhesive stickers and paper stickers; plastic components (foil in rolls; boxes; trays; toy containers; storage bags); polyester storage bags; tissue wrapping paper; paper coated with plastic in rolls; cardboard cartons (non-corrugated; corrugated); rigid paperboard boxes; paper pulp trays; printed labels; molded paper pulp containers; advertising materials; toy set building instructions; nylon components (yarn; string; twine); metal contact plates for battery-powered toy sets; power adapters; batteries (lithium; rechargeable); sound cards; power switches; control hubs for power, sensors, and motors; micro controllers; USB cables with sleeves; sensors (motion; spatial); and, plastic, molded, interlocking bricks and various shapes and figurines (duty rate ranges from duty-free to 17.6%). The request indicates that certain materials/ components are subject to duties under section 301 of the Trade Act of 1974 (section 301), depending on the country of origin. The applicable section 301 decisions require subject merchandise to be admitted to FTZs in privileged foreign status (19 CFR 146.41). Public comment is invited from interested parties. Submissions shall be addressed to the Board’s Executive Secretary and sent to: ftz@trade.gov. The closing period for their receipt is July 11, 2023. A copy of the notification will be available for public inspection in the ‘‘Online FTZ Information System’’ section of the Board’s website. For further information, contact Juanita Chen at juanita.chen@trade.gov. Dated: May 25, 2023. Elizabeth Whiteman, Executive Secretary. [FR Doc. 2023–11618 Filed 5–31–23; 8:45 am] BILLING CODE 3510–DS–P PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 DEPARTMENT OF COMMERCE International Trade Administration Initiation of Five-Year (Sunset) Reviews Enforcement and Compliance, International Trade Administration, Department of Commerce. AGENCY: In accordance with the Tariff Act of 1930, as amended (the Act), the U.S. Department of Commerce (Commerce) is automatically initiating the five-year reviews (Sunset Reviews) of the antidumping duty and countervailing duty (AD/CVD) order(s) and suspended investigation(s) listed below. The U.S. International Trade Commission (ITC) is publishing concurrently with this notice its notice of Institution of Five-Year Reviews which covers the same order(s) and suspended investigation(s). SUMMARY: DATES: Applicable June 1, 2023. FOR FURTHER INFORMATION CONTACT: Commerce official identified in the Initiation of Review section below at AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue, NW, Washington, DC 20230. For information from the ITC, contact Mary Messer, Office of Investigations, U.S. International Trade Commission at (202) 205–3193. SUPPLEMENTARY INFORMATION: Background Commerce’s procedures for the conduct of Sunset Reviews are set forth in its Procedures for Conducting FiveYear (Sunset) Reviews of Antidumping and Countervailing Duty Orders, 63 FR 13516 (March 20, 1998) and 70 FR 62061 (October 28, 2005). Guidance on methodological or analytical issues relevant to Commerce’s conduct of Sunset Reviews is set forth in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty Proceedings; Final Modification, 77 FR 8101 (February 14, 2012). Initiation of Review In accordance with section 751(c) of the Act and 19 CFR 351.218(c), we are initiating the Sunset Reviews of the following antidumping duty and countervailing duty order(s) and suspended investigation(s): E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 88, Number 105 (Thursday, June 1, 2023)]
[Notices]
[Pages 35827-35832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11677]



[[Page 35827]]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2012-0026]


Availability of FSIS Guideline for Controlling Salmonella in 
Swine Slaughter and Pork Processing Establishments

AGENCY: Food Safety and Inspection Service (FSIS), Department of 
Agriculture (USDA).

ACTION: Notice of availability and response to comments.

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

SUMMARY: FSIS is announcing that it has updated its guideline for pork 
producers on controlling Salmonella in swine from pre-harvest through 
slaughter. The guideline covers pre-harvest controls, including farm 
rearing, multi-hurdle interventions, transport, and lairage. It 
contains slaughter control recommendations. It also covers pork 
fabrication controls, including processing, packaging, and distribution 
controls for pork cuts and comminuted pork products. Additionally, FSIS 
is responding to comments on the guideline.

ADDRESSES: A downloadable version of the guideline is available to view 
and print at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/guidelines. No hard copies of the guideline have 
been published.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    On January 6, 2014, FSIS announced in the Federal Register the 
availability of the Compliance Guideline for Controlling Salmonella in 
Market Hogs (79 FR 633).\1\ The guideline provided information on best 
practices that may be applied at a hog slaughter facility to prevent, 
eliminate, or reduce levels of Salmonella on hogs at all stages of 
slaughter and dressing. The guideline was designed to help hog 
slaughter establishments comply with the relevant regulatory 
requirements. When FSIS announced the availability of the guidance, the 
Agency also requested comments on the guidance.
---------------------------------------------------------------------------

    \1\ See: https://www.govinfo.gov/content/pkg/FR-2014-01-06/pdf/2013-31488.pdf.
---------------------------------------------------------------------------

    After review and consideration of all comments received, FSIS has 
made changes to and clarified certain aspects of the guideline. The 
revisions are summarized below and are discussed in more detail in 
FSIS' responses to comments. The revised guideline is available at the 
FSIS guidance web page at https://www.fsis.usda.gov/policy/fsis-guidelines. Although comments on this guideline will no longer be 
accepted through www.regulations.gov, FSIS will continue to update this 
document, as necessary.

Summary of Major Changes to the Guideline

     FSIS changed the document title to FSIS Guideline to 
Control Salmonella in Swine Slaughter and Pork Processing 
Establishments;
     FSIS removed the word ``compliance'' from the document 
title and throughout the guideline to clarify that it does not create 
new regulatory requirements;
     FSIS updated the document to add relevant, current, peer-
reviewed scientific references related to swine slaughter, processing 
of pork cuts, and comminuted pork products;
     FSIS updated the pre-harvest interventions to include 
vaccine and bacteriophage interventions, housing and biosecurity, and 
water and feed management;
     FSIS included a pork products outbreak history;
     FSIS added a policy background section;
     FSIS included FSIS data collection and FSIS pork sampling 
information;
     FSIS added information regarding hot shipping best 
practices;
     FSIS added a lymph node removal best practices section; 
and
     FSIS removed language related to the Trichina guidance, 
new technologies guidance, and validation guidance information, because 
FSIS has separate guidance for these topics.

Comments and Responses

    FSIS received six comments on the guidance, one from a pork 
producer, one from an individual, and four from trade associations 
representing the pork industry. The comment summary and FSIS' responses 
follow.

General

    Comment: Three trade associations stated that the guideline could 
be misinterpreted as regulatory requirements. One of the trade 
associations recommended that, in the final version of the guideline, 
FSIS should clearly state that the best practices set forth are not 
regulatory requirements. Additionally, two of the trade associations 
suggested that FSIS state in the updated guideline that not all 
establishments may be able to implement all best practices, and that 
each establishment must develop and implement their own best practices 
specific to their facility and operation.
    Response: FSIS added language to note that the information in this 
guideline is provided to help swine slaughter establishments meet 
regulatory requirements. FSIS also stated in the guideline that the 
best practices recommended do not have the force and effect of law and 
are not meant to bind the public in any way. The best practice 
recommendations are based on the best scientific and practical 
considerations and are derived from scientific literature. This 
document is intended only to clarify existing regulatory requirements. 
Establishments should select best practice recommendations that work 
for their unique in-plant conditions, equipment, and processes. 
Establishments may choose to adopt different procedures than those 
outlined in the guideline, but they would need to support that those 
procedures are effective in meeting validation requirements and to 
support decisions in the hazard analysis (9 CFR 417.4(a)(1) and 9 CFR 
417.5(a)(1)).
    Comment: A trade association stated that it would be difficult for 
many small and very small establishments to implement many of the best 
practices outlined in the guideline because they may lack technical 
resources. The commenter suggested that FSIS ensure that the best 
practices described in the guideline can be economically and 
consistently implemented by small establishments.
    Response: FSIS updated the guideline to clarify that it is focused 
on small and very small establishments in support of the Small Business 
Administration's initiative to provide small businesses with compliance 
assistance under the Small Business Regulatory Enforcement Fairness 
Act. The guideline includes science-based best practice recommendations 
and scientific citations based on what small and very small 
establishments may have the resources and technical ability to apply in 
the facility. Although all establishments can benefit from the 
information in the guideline, the focus is on the needs of small and 
very small establishments to provide assistance that may be otherwise 
unavailable.
    Comment: A trade association stated that FSIS Enforcement, 
Investigations and Analysis Officers (EIAOs) may not interpret or 
implement the guidance in a consistent manner. The commenter 
recommended that FSIS consider developing a training program to address 
the interpretation and

[[Page 35828]]

enforcement consistency by EIAOs for guidance documents.
    Response: FSIS enforces compliance with statutory and regulatory 
requirements; FSIS does not enforce compliance with guidance documents 
because they do not have the force and effect of law. However, FSIS 
requires EIAOs to review and be familiar with FSIS guidance to provide 
outreach to establishments.
    Comment: Three trade associations recommended removing any 
references to Toxoplasma gondii and Trichinella spiralis in the 
guideline. One trade association further recommended removing any 
references to Campylobacter from the guideline. The commenters argued 
that these pathogens do not fit into a guidance document for 
controlling Salmonella in market hogs.
    Response: FSIS removed all references to Toxoplasma gondii and 
Trichinella spiralis in the guideline because FSIS has a separate 
guidance document that addresses these pathogens. The purpose of this 
guidance document is to assist pork producers on controlling Salmonella 
in swine; therefore, FSIS also removed all references to Campylobacter.
    Comment: A trade association stated that FSIS should provide a 
clearly defined and measurable objective that works towards the goal of 
preventing, eliminating, or reducing levels of Salmonella on hogs. The 
trade organization also argued that the table with non-pathogenic 
indicator organism values, should not be included in the guideline. The 
commenter suggested that the guidance on appropriate action levels for 
non-pathogenic microorganisms should be removed because it did not 
directly relate to the control of Salmonella or any other pathogen.
    Response: FSIS has updated the guidance to include the recent 
Salmonella illness outbreaks related to pork products consumption 
(Table 1), and public health relevance is focused on how pork may be a 
vehicle for salmonellosis. In addition, the table with indicator 
organism criteria limits in market hogs has been removed from the 
guideline. All pork slaughter establishments are required to comply 
with the requirements of 9 CFR 310.18 for evaluation of statistical 
process control to minimize microbial contamination of carcasses, 
reduce microbial pathogens that may be present and injurious to health, 
control the proliferation of any remaining microorganisms, and prevent 
recontamination.
    Comment: A trade association stated that if the guideline contains 
best practices related to temperatures, those temperatures should be 
directly related to the control of Salmonella.
    Response: FSIS updated the temperature recommendations to include 
the latest peer-reviewed research. Several temperature recommendations 
were removed because some small and very small establishments may not 
be able to implement resource-intensive equipment and procedures to 
maintain these temperatures.
    Comment: A pork producer asked FSIS to add recommendations to the 
guideline on how to best control Salmonella in establishments that do 
not utilize polishing equipment and that skin out hogs manually or with 
a hide puller.
    Response: FSIS provided best practice recommendations for commonly 
used steps in the slaughter process. Some establishments processes may 
vary. The guideline includes a recommendation that knives be sanitized 
frequently for establishments that use skinning to remove the hair and 
hide. Additionally, the recommendations for sanitation and using a 
multi-hurdle approach may be applicable to all establishments, 
including those that do not utilize polishing equipment.
    Comment: A pork producer asked FSIS to add recommendations to the 
guideline on how to best control Salmonella in establishments that 
split the body with the head still attached.
    Response: FSIS best practice recommendations for head washing and 
head dropping are important for all establishments, including those 
that split the carcass with the head still attached. FSIS updated the 
guideline to recommend that establishments flush the oral cavity with 
room-temperature water removing ingesta or other contaminants before 
head dropping and FSIS head inspection; maintain and sanitize head 
dropping equipment, as necessary, between carcasses; sanitize knives 
frequently and properly; and maintain and sanitize knives and equipment 
whenever the oral-pharyngeal cavity is sectioned or there is exposure 
to stomach contents.

References and Formatting

    Comment: A pork producer noted that the previous version of the 
guideline contained broken hyperlinks or hyperlinks that do not go to 
the correct location.
    Response: FSIS has updated all hyperlinks and references.
    Comment: The individual commenter asked if the information for 
``McMullen, 2000'' referenced on pages 16 and 24 of the previous 
version of the guideline should be added to the References section.
    Response: FSIS has updated the References section to include the 
correct citation information. This reference is also cited in the 
section titled ``Pre-chill Final Rinse, Hot Rinse, and Steam 
Pasteurization.''
    Comment: Two trade associations suggested that FSIS update the 
scientific references to the most recent research from the United 
States. The commenters argued that most of the references are outdated 
and many of the studies referenced in the guideline were conducted in 
other countries and are not applicable in the United States. Another 
trade association requested that the guideline contain a reference or 
citation after each recommended best practice.
    Response: FSIS has updated all the references, removed outdated 
references, and included nearly 100 new peer-reviewed references to 
assist small and very small establishments in accessing the latest 
research and scientific support. The references are listed at the end 
of the document and are also cited in each pertinent section throughout 
the guideline for ease-of-use for small and very small establishments.

Salmonella in Market Hogs

    Comment: A trade association asked if there is a link between the 
FSIS market hog Salmonella baseline and public health risk.
    Response: FSIS has updated the guideline to include the latest FSIS 
sampling data from the Raw Pork Products Exploratory Sampling 
Program.\2\ These updates provide a recent, thorough analysis of 
Salmonella prevalence in market hogs and the public health risk.
---------------------------------------------------------------------------

    \2\ See: https://www.fsis.usda.gov/science-data/sampling-
program/raw-pork-products-exploratory-sampling-
program#:~:text=FSIS%20announced%20the%20launch%20of,organisms% 
20in%20various%20pork%20products.
---------------------------------------------------------------------------

    Comment: A trade association asked what type of pork caused the 
outbreaks discussed in the guideline and if the pork was produced under 
FSIS inspection.
    Response: FSIS has updated the guidance to include the recent 
illness outbreaks related to pork products consumption. Table 1 lists 
each pork product implicated in each of the 36 illness outbreaks from 
2014-2019. Retail product associated with outbreaks is typically 
inspected by FSIS or by State inspection programs. However, there have 
also been outbreaks from whole roaster hogs at church events, etc., 
that were from non-FSIS inspected sources.

[[Page 35829]]

Farm Rearing

    Comment: Two trade associations recommended adding additional best 
practices to the farm rearing section of the guideline on the use of 
vaccination in herds and on the use of non-pelleted feed.
    Response: FSIS updated the section on farm rearing to include 
housing and biosecurity measures. In addition, FSIS included sections 
on preharvest controls for water and feed management and pre-harvest 
vaccine and bacteriophage interventions.
    Comment: A trade association representing the pork industry argued 
that the best practice recommendations for farm rearing and transport 
should not be included in the guideline. The commenter argued that in 
most cases, establishments have little, if any, influence on such 
practices and that FSIS does not have jurisdiction to regulate on-farm 
practices.
    Response: FSIS recommends establishments work closely and establish 
communication with their livestock suppliers to identify and address 
on-farm controls as a means of targeting multiple areas of swine 
production through pre-harvest control of Salmonella coming into 
slaughter establishments. FSIS updated the section on live animal 
transport and lairage with best practice recommendations based on 
current scientific research because microbiological contamination in 
the slaughterhouse environment can start with the delivery of 
Salmonella-positive hogs. Control of Salmonella at the herd level is 
critical to prevent the spread on-farm, through hygienic processes, 
feed and water management, live animal transport, and lairage before 
hogs reach the slaughter line. Stress during transport and many on-farm 
factors play a significant role in spreading Salmonella.

Lairage

    Comment: Four trade associations commented that the best practice 
to disinfect lairage pens and alley ways between herds (using 
chlorinated alkaline detergent followed by disinfection with a 
quaternary ammonium solution) is overly burdensome and may not be 
practical for every establishment. One of these trade associations 
stated that there is literature to support that there are other 
cleaners and sanitizers that would be equally effective. Another trade 
group commented during ongoing production operations, constant 
application of cleaning solutions is not practical, cost effective, or 
often even possible due to the logistics of creating space for incoming 
loads and moving hogs on to harvest in a continuous line. The commenter 
suggested that implementing such a recommendation in many 
establishments could lead to crowding or unnecessary agitation of the 
hogs. The commenter stated that it is more practical for establishments 
to clean and sanitize the pens and alleyways when the building and 
structures are empty or close to empty.
    Response: FSIS updated the guideline to recognize that there are 
numerous cleaners and sanitizers with varying application parameters 
and frequencies that establishments may choose to use and to recognize 
that those decisions should be based on the unique characteristics of 
an establishment's food safety plan and available support. FSIS also 
included in the guidance that it is often practical to clean and 
sanitize pens and alleyways when they are empty.
    Comment: A trade association noted that the guideline recommends 
ensuring that hogs are washed clean (pen shower) and dry enough to 
preclude dripping at the time of stunning. The commenter and two other 
trade associations noted that this practice may not be practical for 
many establishments, because showering pigs in colder weather may raise 
animal welfare issues in addition to the possibility of ice formation.
    Response: In the guidance, FSIS recommends that the hogs should be 
dry enough to prevent dripping at the time of stunning; if they are 
dripping, the moisture may contribute to cross-contamination during 
stunning, sticking, or skinning, for those establishments that skin the 
carcasses instead of using a dehairing machine. FSIS updated the 
guidance to state that pen showers are also important measures to 
ensure that hogs are washed clean, when appropriate. FSIS recommends 
establishments consider weather conditions to determine whether it is 
appropriate to use pen showers. Consistent with the commenters, in the 
guidance, FSIS recognizes cold conditions and ice formation may create 
an animal welfare concern.
    Comment: Three trade associations asserted that the best practice 
recommendation for minimizing the time hogs are held in lairage had two 
key problems. The first is that the guideline does not specify a 
recommended ``minimum'' time that pigs should be held in lairage. 
Secondly, if pigs are not held in lairage at all, that would compromise 
pork quality, may result in high incidence of pale soft exudative 
conditions, and increases Salmonella contamination.
    Response: In the guidance, FSIS does not give a minimum time for 
holding hogs in lairage. Rather, FSIS recommends that establishments 
use a variety of preventive measures at lairage to prevent and reduce 
the spread of Salmonella among the herd, including minimizing the time 
that hogs are held in lairage and preventing overcrowding during time 
in lairage. Also in the guidance, FSIS encourages further study and 
solutions by industry in controlling and reducing the spread of 
Salmonella in hog slaughter facilities with particular attention to 
controls at lairage.
    Comment: A trade association recommended the best practice to use 
slatted or elevated floors in lairage pens to reduce waste and water 
accumulation. The commenter stated that, while this may be useful to 
those considering new construction or retrofitting, it would be cost-
prohibitive for most existing facilities. The commenter further stated 
that many existing operations achieve acceptable results using sloped 
floors with proper drainage and effective cleaning and sanitizing.
    Response: The guidance recommends that establishments maintain 
lairage pens in good condition to prevent injury to animals, and that 
slatted, sloped, or elevated floors are important to reduce waste and 
water accumulation that can contribute to the spread of Salmonella. 
FSIS best practice recommendations do not require establishments to 
retrofit an existing facility.
    Comment: A trade association representing the pork industry noted 
the guideline contains a ``highlight box'' indicating that lairage is 
the most cost-effective stage to prevent cross-contamination. The 
commenter stated that while lairage is currently a vulnerability for 
pigs to become infected, the commenter was not aware of specific 
scientific evidence to be able to document that it is the most cost-
effective stage to prevent cross-contamination. The commenter stated 
that an establishment's hazard analysis should be used to make the 
determination of locations and cost-effectiveness.
    Response: FSIS does state in the text of the guideline that a 
scientific study has shown that controls at lairage are cost-effective 
measures an establishment can take to prevent cross-contamination that 
leads to rapid infection (Van der Gaag et al., 2004). The statement has 
been removed from the highlight box. As stated in the guideline, 
establishments should select best

[[Page 35830]]

practice recommendations that work for the unique in-plant conditions, 
equipment, and processes.

Slaughter/Bleeding

    Comment: A trade association recommended that FSIS rename the 
``Slaughter/Bleeding'' step and section heading to ``Bleeding.''
    Response: FSIS has renamed the section heading to Bleeding.
    Comment: Two trade associations argued that although stick knives 
have tested positive for Salmonella in several studies, there is very 
little data to suggest that they are a ``significant source'' for 
Salmonella contamination.
    Response: FSIS recommends that knives be sanitized between each 
carcass. Contamination of knives, boots, the number of gut ruptures, 
mechanical problems, or other factors, which are common process points 
for handling and cross-contamination, were factors significantly 
associated with the prevalence of Salmonella on the carcasses in 
research studies (Botteldoorn et al., 2003; Letellier et al., 2009).

Scalding

    Comment: Two of the industry groups noted that the statement 
references 5 [deg]F (41 [deg]C) should read 105 [deg]F (41 [deg]C).
    Response: FSIS has corrected typographical errors and temperatures, 
and the section has been updated with additional peer-reviewed 
references.
    Comment: A trade association stated that many establishments use 
scalding temperatures and times other than those referenced in the 
guideline, and this should be reflected in the guidance document.
    Response: The Scalding section has been updated with additional 
peer-reviewed references, including other temperature/time combinations 
that have been shown to be effective in various studies.
    Comment: A trade association recommended that FSIS update the 
guideline to state that establishments should consider the type of hog, 
season, and equipment when determining the appropriate scalding 
temperature and duration.
    Response: FSIS updated the guidance to state that FSIS recommends 
considering the type of hog, season, and the equipment being used to 
determine and support the appropriate scalding temperature and 
duration.

De-Hairing

    Comment: Two trade associations stated that the suggested best 
practice of cleaning and disinfecting de-hairing equipment, preferably 
using a clean-in place (CIP) system, which may be applied on an ongoing 
basis throughout production, is not practical for this type of 
equipment. The industry groups argued that not all de-hairing equipment 
can be retrofitted with CIP systems, and many small establishments use 
self-contained scalders which simultaneously de-hair the carcass.
    Response: FSIS updated the guideline to reflect that some 
establishments may find using a CIP system throughout production 
beneficial since it can be applied on an ongoing basis; however, FSIS 
recognizes in the guideline that such a system requires significant 
investment and appropriate equipment. As stated in the guideline, 
establishments should select best practice recommendations that work 
for the unique in-plant conditions, equipment, and processes.
    Comment: Two trade associations stated that the suggested best 
practice for removing all organic material and debris from de-hairing 
equipment at the end of the day is overly burdensome. The commenters 
stated that there are many effective ways to clean and disinfect de-
hairing equipment and that specifying water pressures, types of 
chemicals, and contact times does not allow for flexibility.
    Response: FSIS removed several specific temperature and 
antimicrobial intervention recommendations because some small and very 
small establishments may not be able to implement the use of resource-
intensive equipment and procedures. As stated in the guideline, FSIS 
recommends that intervention and control strategies be formulated based 
on a combination of measures that are both practical and economically 
feasible.
    Comment: Two trade associations argued that the suggested best 
practice to ``use water between 140[deg] to 144 [deg]F (60 [deg]C to 62 
[deg]C) in the de-hairing machine if the water is not chemically 
treated (7 ICMSF, 1998)'' may not be practical depending on the type of 
equipment used.
    Response: FSIS included several best practice recommendations in 
the updated guideline, depending on the equipment type used. FSIS also 
recommended that establishments ensure that equipment can be cleaned 
and disinfected to comply with 9 CFR 416.3. As stated in the guideline, 
establishments should select best practice recommendations that work 
for the unique in-plant conditions, equipment, and processes. FSIS 
recommends that intervention and control strategies be formulated based 
on a combination of measures that are both practical and economically 
feasible.
    Comment: A pork producer asked FSIS to add recommendations to the 
guideline on how to best control Salmonella in very small 
establishments that do not utilize de-hairing tanks.
    Response: FSIS provided best practice recommendations for commonly 
used steps in the slaughter process. FSIS did not update the guideline 
to include a separate section for establishments that do not use de-
hairing tanks, but does address skinning hogs in the guidance. FSIS 
added a recommendation that knives be sanitized frequently for 
establishments that use skinning to remove the hair and hide. 
Additionally, the recommendations for sanitation and using a multi-
hurdle approach may be applicable to all establishments, including 
those that do not utilize de-hairing tanks.

Steam/Hot Water Vacuuming

    Comment: Two trade associations stated that the Steam/Hot Water 
Vacuuming section was out of place in the document and blends 
information on steam vacuuming and carcass washing into a single 
section. The industry groups argued that it is unlikely that these 
interventions would be applied between the gambrelling and singeing 
processes.
    Response: FSIS has reorganized the guidance to be reflective of the 
steps of the process and added new sections (e.g., multi-hurdle 
intervention approach, pre-harvest sections, lymph node removal, 
shipping practices) to provide thorough best practice recommendations. 
In addition, FSIS has separated steam and hot water vacuum 
interventions from carcass rinses and washes to reflect the typical 
order of interventions in-plant.

Singeing Best Practices

    Comment: A pork producer asked what best practices FSIS would 
recommend for small establishments to control Salmonella that do not 
utilize singeing cabinets.
    Response: FSIS provided best practice recommendations for commonly 
used steps in the slaughter process. Some establishments processes may 
vary, and some establishments may use skinning rather than scalding, 
dehairing, and singeing. FSIS recommends that intervention and control 
strategies be formulated based on a combination of measures that are 
both practical and economically feasible.

[[Page 35831]]

Pre-Evisceration Carcass Rinse or Spray

    Comment: Two trade associations noted the suggested best practice 
to use water at a temperature greater than 160 [deg]F (71.1 [deg]C) and 
stated that there is support for using lower temperatures.
    Response: FSIS removed specific temperatures from this section of 
the guideline.
    Comment: A trade association representing the pork industry 
commented on the best practice that recommends that the pressure for 
carcass sprays not exceed 100 PSI to prevent driving contamination into 
the tissue. The commenter questioned what tissue the contamination 
would potentially be driven into.
    Response: FSIS has removed all reference to 100 PSI pressure spray 
from the guidance document. The guidance includes FSIS recommended best 
practices when using pre-evisceration carcass rinses and sprays. FSIS 
does recommend that monitoring pressure is important to prevent driving 
microbiological contamination into the carcass tissue.
    Comment: A trade association asked how the suggested best practice 
to minimize overspray of water or solution from the cabinet is 
associated with food safety.
    Response: FSIS has updated the guidance to reflect that 
establishments should minimize splash onto other carcasses to prevent 
potential cross-contamination. Airborne bacterial contamination has 
been shown to spread; therefore, FSIS recommends establishments take 
precautions to limit overspray and aerosolization through techniques 
and equipment.
    Comment: Two trade associations asked if the best practice 
recommendation of using a post-evisceration rinse or spray to further 
reduce carcass contamination is another practice prior to a final 
carcass wash. The industry groups further asked if application of a 
final carcass wash is a regulatory requirement.
    Response: While a final carcass wash is not a regulatory 
requirement for swine slaughter establishments, FSIS recommends carcass 
decontamination treatments before chilling and that intervention and 
control strategies be formulated based on a combination of measures 
that are both practical and economically feasible. Studies have shown 
that processing procedures, such as decontamination treatments after 
evisceration and carcass splitting, generally result in decreased 
prevalence of Salmonella as the carcasses move toward the cooler.
    Comment: A trade association recommended FSIS clarify 
recommendations concerning applying organic acids.
    Response: FSIS has updated the guideline to state that automated 
spray cabinets or handheld sprayers may be used, bearing in mind that 
the effectiveness of the interventions vary based on the critical 
operational parameters used, and appropriate scientific support is 
required for establishments using interventions.

Bung Isolation

    Comment: Two trade associations requested FSIS clarify the guidance 
concerning bung isolation.
    Response: FSIS updated the guideline to state that FSIS recommends 
establishments bag and tie the bung before evisceration, ensuring staff 
pay specific attention to minimizing cross-contamination of the carcass 
and viscera. FSIS recommends that intervention and control strategies 
be formulated based on a combination of measures that are both 
practical and economically feasible.

Pre-Chill Final Rinse/Hot Rinse/Steam Pasteurization

    Comment: Two trade associations recommended that FSIS provide 
guidance for the upper limits on water pressure for washing carcasses.
    Response: FSIS removed specific requirements for pressure in the 
guidance because the efficacy of these interventions can vary depending 
on the specific critical operational parameters used, including water 
temperature, water pressure, length of application, and chemical 
concentration. FSIS best practice recommendations state that 
establishments should implement decontamination and antimicrobial 
interventions using appropriate critical operational parameters.
    Comment: A trade association stated that there are many other 
antimicrobial rinses that can be applied, and that limiting the 
recommendation to lactic or acetic acid may imply that it is the only 
antimicrobial that can be used.
    Response: FSIS updated the guideline to include a variety of 
antimicrobial interventions supported by the literature.
    Comment: A trade association representing the pork industry 
suggested that FSIS mention antimicrobials in this section. The 
commenter noted that FSIS could provide references that include 
specific examples as a useful tool to assist the small and very small 
establishments.
    Response: FSIS updated the guideline to provide best practice 
recommendations, which include a variety of antimicrobial interventions 
supported by the literature. FSIS provided information and citations to 
potential antimicrobial interventions, including chlorine, trisodium 
phosphate, lactic acid, and acetic acid.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online 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 
can 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.

USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and 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,

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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;
    (2) Fax: (833) 256-1665 or (202) 690-7442; or
    (3) Email: [email protected].
    USDA is an equal opportunity provider, employer, and lender.

    Done at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2023-11677 Filed 5-31-23; 8:45 am]
BILLING CODE 3410-DM-P
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