2023-11677. 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: [phone].

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.

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 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.

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.

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 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 °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 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° 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 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.

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 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: http://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.

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Footnotes

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

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.