Under the current system, facilities look at prevalence of Salmonella using an absence/presence analysis. and based on this, a facility is judged as meeting or not meeting the established standard. In the proposed system, establishments will look at number of Salmonella as well as determine if certain infectious strains are present.
"FSIS is proposing final product standards that would define whether certain raw poultry products contaminated with certain Salmonella levels and serotypes are adulterated as defined in the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.). Specifically, FSIS has tentatively determined that raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey are adulterated if they contain any type of Salmonella at or above 10 colony forming units/per milliliter or gram (10 cfu/mL(g)) in analytical portion (i.e., mL of rinsate or gram of product) and contain any detectable level of at least one of the Salmonella serotypes of public health significance identified for that commodity."
"The proposed Salmonella serotypes of public health significance identified for raw chicken carcasses, chicken parts, and comminuted chicken are Enteritidis, Typhimurium, and I 4,[5],12:i:-, and for raw comminuted turkey are Hadar, Typhimurium, and Muenchen. These are the most highly virulent Salmonella serotypes associated with these products identified in the FSIS chicken and turkey risk assessments."
USDA would conduct sampling of products from the facility.
"The Agency intends to conduct a routine sampling and verification testing program for Salmonella in chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey in which the Agency would collect samples of raw final products and analyze them for Salmonella levels and serotypes to determine whether the final product is adulterated. Under the proposed Salmonella verification testing program, FSIS intends to only collect and analyze samples of the final raw poultry products produced by an establishment, i.e., chicken carcasses to be shipped in commerce as whole chickens, chicken parts to be shipped in commerce as chicken parts, comminuted chicken to be shipped in commerce as comminuted chicken products, and comminuted turkey to be shipped in commerce as comminuted turkey products."
USDA would require facilities to establish controls, and as part of that, verification testing.
USDA will "establish new requirements pertaining to how establishments monitor and document whether their processes for preventing microbial contamination are in control. The proposed revisions are intended to clarify existing regulatory requirements related to process control monitoring in 9 CFR 381.65(g) and (h). Under this proposal, establishments would be required to incorporate statistical process control (SPC) monitoring principles into their microbial monitoring programs (MMPs). The proposed revisions would require that establishments use only validated and fit for purpose microbial sampling and analysis procedures, generate and record statistically meaningful microbial monitoring data, set benchmarks by which to evaluate microbial monitoring data, and otherwise define the statistical methods the establishment will use to evaluate the recorded data against the predefined limits.""FSIS is proposing to specifically require establishments to, at a minimum, implement written corrective actions, including a root cause assessment, when microbial monitoring results deviate from the predefined criteria in the MMP, the other process control monitoring results, or the process control determination made for the entire HACCP system. FSIS has developed new guidance to help establishments meet the proposed updated sampling and analysis requirements under 9 CFR 381.65(g). The new guidance includes a SPC sampling plan based on paired sampling for Aerobic Count (AC) at the rehang and post-chill locations, with a one-sided process control statistical model that charts and calculates against minimum monitoring criteria at the minimum required frequency. Establishments that incorporate the guidance into their MMPs would not be required to provide FSIS with additional scientific or technical information to support their chosen statistical methods.""FSIS is proposing to amend the recordkeeping requirements under 9 CFR 381.65(h) to require that establishments submit their microbial monitoring sampling results to FSIS electronically. FSIS is developing a web portal that will allow external partners to securely upload sampling information and submit it to FSIS electronically in a machine-readable format."
July 29, 2024
Special Alert
USDA Proposes New Policy to Reduce Salmonella in Raw Poultry Products
Today, FSIS issued a comprehensive proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products. This is the culmination of FSIS’ three-year effort to reevaluate their strategy for controlling Salmonella rates in poultry and protect American consumers from foodborne illness linked to consumption of poultry products.
Salmonella bacteria cause over 1 million human infections in the United States each year, according to the Centers for Disease Control and Prevention (CDC). Food is the leading source of Salmonella infections and poultry is among the leading sources of foodborne Salmonella illnesses. FSIS estimates that there are 125,000 chicken-associated and almost 43,000 turkey-associated foodborne Salmonella illnesses per year. Despite FSIS data indicating that Salmonella contamination in poultry products has been decreasing, there has not been an observed reduction in Salmonella illnesses.
The proposal would establish final product standards to prevent raw chicken carcasses, chicken parts, ground chicken, and ground turkey products that contain any type of Salmonella at or above 10 colony forming units (CFU) per gram/ml and any detectable level of at least one of the Salmonella serotypes of public health significance from entering commerce. The proposed Salmonella serotypes of public health significance identified for raw chicken carcasses, chicken parts, and comminuted chicken are Enteritidis, Typhimurium, and I,4,[5],12:I:- ; and for raw comminuted turkey are Hadar, Typhimurium, and Muenchen. The proposal would also require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination throughout the slaughter system.
Since 2021, FSIS initiated several activities designed to gather data and information to inform the framework proposed rule and determination. These activities included; charging the National Committee on Microbiological Criteria for Food to provide guidance on the types of microbiological criteria the agency might use to better prevent Salmonella infections associated with poultry products; conducting a risk profile for pathogenic Salmonella subtypes in poultry and developing two quantitative risk assessments; hosting a public meeting and several roundtables; conducting an exploratory sampling program for young chicken carcasses to generate microbial data and adding quantification to FSIS’ Salmonella testing program.
The Salmonella framework proposed rule and determination builds on FSIS’ continued efforts under the Biden-Harris Administration to protect American consumers, including preventing false and misleading label claims. As part of this effort, earlier this year, FSIS published a final determination to declare Salmonella an adulterant in raw breaded stuffed chicken products when they exceed the threshold of 1 CFU per gram of Salmonella contamination. FSIS also announced this year a final rule allowing the voluntary “Product of USA” claim to be applied only to those FSIS-regulated products that are derived from animals born, raised, slaughtered and processed in the United States.
Comments on this proposal must be received within 60 days after publication in the Federal Register.
Comments may be submitted online via the federal eRulemaking portal, available at www.regulations.gov; by mail sent to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, D.C. 20250-3700, or by hand or courier delivery to 1400 Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, D.C. 20250-3700. All items submitted by mail or electronic mail must include the agency name and docket number FSIS-2023-0028.
https://www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-rules/salmonella-framework-raw-poultry-products
Advance Copy: Salmonella Framework for Raw Poultry Products
Docket Number
Docket No. FSIS-2023-0028:
Federal Register Status
Advance Notice of Proposed Rulemaking
Proposed Date
Jul 29, 2024
Summary of the Proposed Rule:
FSIS is announcing its proposed determination that raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products contaminated with certain Salmonella levels and serotypes are adulterated within the meaning of the Poultry Products Inspection Act (PPIA). The proposed determination would establish final product standards based on these Salmonella levels and serotypes and would prevent raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products that contain Salmonella at the levels and serotypes that would render them adulterated from entering commerce. FSIS is also proposing to revise the regulations that require that all poultry slaughter establishments develop, implement, and maintain written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operation to clarify that these procedures must include a microbial monitoring program (MMP) that incorporates statistical process control (SPC) monitoring methods, to require sampling at rehang instead of pre-chill, and to require that all establishments conduct paired sampling at rehang and post-chill.
While the results of FSIS’ Salmonella verification sampling show that the current prevalence-based performance standards approach has been effective in reducing the proportion of poultry products contaminated with Salmonella, these measures have yet to have an observable impact on human illness rates. The estimated rate of human Salmonella infections from all sources has remained consistent over the last two decades, with over 1.3 million illnesses estimated in the United States each year. Additionally, while current Salmonella performance standards are designed to achieve the Department of Health and Human Services’ Healthy People Initiative1 targets for foodborne illness reduction, the 2010 and 2020 Healthy People targets for a reduction in Salmonella infections from all sources were not met. The Healthy People 2030 target is to reduce Salmonella infections from all sources to a national case rate of no more than 11.5 per 100,000 consumers per year. To reach this 2030 target, Salmonella illnesses must be reduced by 25 percent. Poultry is among the leading sources of Salmonella foodborne illness acquired domestically in the United States.2 Therefore, on October 19, 2021, FSIS announced that it was mobilizing a stronger, and more comprehensive effort to reduce Salmonella illnesses associated with poultry products
First, consistent with Component Three of the October 2022 draft framework, FSIS is proposing final product standards that would define whether certain raw poultry products contaminated with certain Salmonella levels and serotypes are adulterated as defined in the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.). Specifically, FSIS has tentatively determined that raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey are adulterated if they contain any type of Salmonella at or above 10 colony forming units/per milliliter or gram (10 cfu/mL(g)) in analytical portion (i.e., mL of rinsate or gram of product) and contain any detectable level of at least one of the Salmonella serotypes of public health significance identified for that commodity. The proposed Salmonella serotypes of public health significance identified for raw chicken carcasses, chicken parts, and comminuted chicken are Enteritidis, Typhimurium, and I 4,[5],12:i:-, and for raw comminuted turkey are Hadar, Typhimurium, and Muenchen. These are the most highly virulent Salmonella serotypes associated with these products identified in the FSIS chicken and turkey risk assessments.
The Salmonella serotypes of public health significance will likely change over time as the serotypes commonly associated with human illnesses change. FSIS would continue to track annual targets for reducing the proportion of poultry samples that contain Salmonella serotypes of public health significance as well as data on rates for additional serotypes commonly associated with human illness to inform future revisions to the Salmonella serotypes of public health significance. Should FSIS finalize the proposed final product standards, the Agency intends to further evaluate and, if necessary, refine these standards as advances in science and technology related to pathogen levels, serotypes, and virulence genes become available. If FSIS finalizes the proposed final product standards, the Agency intends to reevaluate the serotypes of public health concern every 3-5 years at a minimum and whenever new information on Salmonella serotypes associated with human illness become available.
When evaluating the serotypes, FSIS would consider, among other things, outbreak illness data,
foodborne illness surveillance data, product testing data, and animal testing data. Should FSIS finalize these proposed standards, the Agency intends to conduct a routine sampling and verification testing program for Salmonella in chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey in which the Agency would collect samples of raw final products and analyze them for Salmonella levels and serotypes to determine whether the final product is adulterated. Under the proposed Salmonella verification testing program, FSIS intends to only collect and analyze samples of the final raw poultry products produced by an establishment, i.e., chicken carcasses to be shipped in commerce as whole chickens, chicken parts to be shipped in commerce as chicken parts, comminuted chicken to be shipped in commerce as comminuted chicken products, and comminuted turkey to be shipped in commerce as comminuted turkey products. Under this proposed determination, chicken parts subject to the final product standards would include legs, thighs, breasts, wings, quarters, and
halves.
When FSIS tests a product sample for adulterants, establishments must maintain control of products tested for adulterants to ensure that the products do not enter commerce while waiting for receipt of the test results. Thus, if FSIS finalizes its proposed routine Salmonella verification testing program for chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey, establishments that produce these raw products would need to control and maintain the integrity of the sampled lot pending the availability of test results. If test results detect Salmonella at a level of 10 cfu/mL(g) or higher and at least one Salmonella serotype of public health significance, FSIS would consider products represented by the sampled lots to be adulterated and would issue a non-compliance record (NR). Therefore, all products in the lot represented by the sample would be prohibited from entering commerce. If any product from the lot represented by the product samples has entered and remains
available in commerce, FSIS would request that the producing establishment recall the
implicated products. Depending on the circumstances, in addition to issuing an NR, FSIS could take other appropriate enforcement action
Consistent with Component Two of the initial proposed framework, FSIS is proposing to revise the regulations in 9 CFR 381.65(g) and (h) that require that all poultry slaughter establishments develop, implement, and maintain written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operation and maintain records documenting those procedures. FSIS is proposing to amend these regulations to establish new requirements pertaining to how establishments monitor and document whether their processes for preventing microbial contamination are in control. The proposed revisions are intended to clarify existing regulatory requirements related to process control monitoring in 9 CFR 381.65(g) and (h). Under this proposal, establishments would be required to incorporate statistical process control (SPC) monitoring principles into their microbial monitoring programs (MMPs). The proposed revisions would require that establishments use only validated and fit for purpose microbial sampling and analysis procedures, generate and record statistically meaningful microbial monitoring data, set benchmarks by which to evaluate microbial monitoring data, and otherwise define the statistical methods the establishment will use to evaluate the recorded data against the predefined limits. To offset the costs associated with this proposal, eligible
very small (VS) and very low volume (VLV) establishments would have access to laboratory services provided by FSIS at no charge to analyze the establishments’ microbial monitoring samples for them.
FSIS is further proposing to revise the regulations to ensure that establishments comply with the corrective action provisions required under HACCP as they apply to the establishment’s MMP. FSIS is proposing to specifically require establishments to, at a minimum, implement written corrective actions, including a root cause assessment, when microbial monitoring results deviate from the predefined criteria in the MMP, the other process control monitoring results, or the process control determination made for the entire HACCP system. FSIS has developed new guidance to help establishments meet the proposed updated sampling and analysis requirements under 9 CFR 381.65(g). The new guidance includes a SPC sampling plan based on paired sampling for Aerobic Count (AC) at the rehang and post-chill locations, with a one-sided process control statistical model that charts and calculates against
minimum monitoring criteria at the minimum required frequency. Establishments that incorporate the guidance into their MMPs would not be required to provide FSIS with additional scientific or technical information to support their chosen statistical methods. FSIS also is proposing to make available to all poultry slaughter establishments an electronic spreadsheet file that is pre-programmed to calculate the monitoring measures for the guidance sampling plan as results are entered.
In addition, FSIS is proposing to amend the recordkeeping requirements under 9 CFR 381.65(h) to require that establishments submit their microbial monitoring sampling results to FSIS electronically. FSIS is developing a web portal that will allow external partners to securely upload sampling information and submit it to FSIS electronically in a machine-readable form at.
Should FSIS finalize this proposal, the Agency would provide a template that establishments could use to record and submit their monthly results. Establishments that use the template to record the microbial monitoring results may upload their completed template into the portal or they may enter the information manually into the portal. Establishments that do not use the template provided by FSIS to record their results would need to manually enter microbial sampling data into the portal to submit the monthly data.
PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS
1. The authority citation for part 381 continues to read as follows:
Advance copy of document submitted to the Office of the Federal Register. May be subject to minor
changes.
245
Authority: 7 U.S.C. 138f, 1633; 21 U.S.C. 451–472; 7 CFR 2.7, 2.18, 2.53.
2. Amend 9 CFR 381.65 as follows:
a. Revise paragraph (g)
b. Revise paragraph (h)
The revisions would read as follows:
§ 381.65 Operations and procedures, generally.
* * * * *
381.65(g) Procedures for controlling contamination throughout the slaughter and dressing operation. Official poultry slaughter establishments must develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens and fecal contamination throughout the entire slaughter and dressing operation. Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, or other prerequisite programs. At a minimum, these procedures must establish a microbial monitoring program that includes sampling and analysis of microbial organisms in accordance with the requirements in paragraphs(g)(1)-(5) of this section to monitor an establishment’s ability to maintain process control.
(1) Sampling locations. Establishments must collect and analyze samples for microbial organisms at the rehang and post-chill points in the process.
(i) The establishment’s microbial monitoring program must identify and provide supporting rationale for the specific point in the process where rehang and post-chill samples will be collected.
(ii) An establishment may collect samples at a location other than rehang if the establishment
provides supporting data to demonstrate that the alternate location is at least as effective as
rehang sampling for monitoring the establishment’s ability to maintain process control.
(2) Sampling frequency.
(i) Except as provided in paragraph (g)(2)(ii) of this section, all official poultry establishments
must collect and analyze paired monitoring samples at the following rates. Establishments that
slaughter multiple species may conduct sampling on the type of poultry slaughtered in the
greatest number.
Table B for Turkey
(ii) Very low volume establishments as defined in subparagraphs (g)(2)(i)(A) and (B) of this section that plan to operate less than 13 weeks per year may collect and analyze 13 samples less than weekly if the establishment can demonstrate that it is effectively maintaining process control throughout the year and during any periods of slaughter operations.
(iii) Establishments must sample at a frequency that is adequate to monitor their ability to maintain process control for enteric pathogens.
(iv) Establishments must maintain accurate records of all test results and retain these records as provided in paragraph(h) of this section.
(3) Microbial Organism and Methods. Establishments must analyze monitoring samples for microbial organisms that are quantifiably detectable in their slaughter process and that will generate microbial monitoring data that is adequate to monitor their ability to maintain process control for enteric pathogens.
(i) The establishment’s measured results at each sample location must yield statistically reliable quantified value results
(ii) The establishments’ sample collection method must be appropriate for the product sampled, the microbial organism monitored, and the laboratory method used to analyze the samples.
(iii) The establishment’s microbial sampling results must be generated by validated laboratory analyses and methods.
(4) Microbial Monitoring Criteria. The establishment must use appropriate statistical methods to compare microbial monitoring data against predefined quantitative limits adequate to gauge its ability to maintain process control. At a minimum, the microbial monitoring program must identify and support limits for:
(i) The minimal expected change in microbial levels measured between sampling locations;
and
(ii) The expected consistency of the levels of change detected over a specified monitoring period.
(5) Corrective Actions. The establishment must implement written corrective actions, including a root cause assessment, at a minimum when:
(i) The microbial monitoring results deviate from predefined quantitative limits;
(ii) The microbial monitoring results are not consistent with the other process control monitoring results for the same procedures; or
(iii) The microbial monitoring results are not consistent with the process control determination made for the entire slaughter HACCP system.
(h) Recordkeeping requirements. Official poultry slaughter establishments must maintain daily records sufficient to document the implementation and monitoring of the procedures required under paragraph (g) of this section. Records required by this section may be maintained on computers if the establishment implements appropriate controls to ensure the integrity of the electronic data. Records required by this section must be maintained for at least one year and must be accessible to FSIS.
(1) Official poultry slaughter establishments must submit their microbial sampling results to
FSIS electronically on a monthly basis.
https://www.morningagclips.com/national-turkey-federation-statement-on-fsis-salmonella-framework-proposed-rule/
National Turkey Federation Statement on FSIS Salmonella Framework Proposed Rule
"NTF believes any standard should be science-based and should not impose unnecessary costs and product destruction for members of the U.S. turkey industry."
PUBLISHED ON July 30, 2024
WASHINGTON — The National Turkey Federation (NTF) issued the following statement on the release of the USDA Food Safety and Inspection Service’s (FSIS) Salmonella Framework Proposed Rule:
“Since the release of FSIS’ Proposed Regulatory Framework to Reduce Salmonella Illnesses Attributable to Poultry in 2022, the National Turkey Federation (NTF) and its members have actively contributed industry data to the FSIS Salmonella Risk Assessment and maintained an ongoing dialogue with the agency to identify effective, practical solutions that build on the turkey industry’s ongoing efforts to combat Salmonella throughout turkey production.
“Regarding the Salmonella Framework, while NTF believes that FSIS already possesses the authority and regulatory tools necessary to drive improvements in food safety without implementing a final product standard for Salmonella in turkey products, we will diligently review and provide meaningful comment on the proposal. NTF believes any standard should be science-based and should not impose unnecessary costs and product destruction for members of the U.S. turkey industry.
“As we delve deeper into the Salmonella Framework, NTF is committed to continuing our engagement with FSIS to develop comprehensive strategies that will advance this crucial priority while reflecting the concerns of NTF members expressed throughout this policy progression.”
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