Regulatory Waivers and the Salmonella Initiative Program
FSIS regulations (specifically 9 CFR 303.1(h), 381.3(b), and 590.10) authorize the Administrator to waive for limited periods any provisions of the regulations so that new procedures, equipment, and processing techniques may be tested to facilitate definite improvements. As described in the July 13, 2011, Federal Register notice, Salmonella Verification Sampling Program: Response to Comments on New Agency Policies and Clarification of Timeline for the Salmonella Initiative Program (SIP), “[the] Salmonella Initiative Program (SIP) [is] for meat and poultry slaughter establishments that agree to share internal food safety data with FSIS in order to receive waivers of regulatory requirements. The SIP benefits public health in that it encourages slaughter establishments to test for microbial pathogens and to respond to the ongoing results by taking steps when necessary to regain process control and thus to minimize the presence of pathogens of public health concern.”
FSIS is aware that some poultry establishments would like to propose other regulatory waivers, such as alternative sampling frequencies to 381.65(g) or to apply New Poultry Inspection System (NPIS) parameters to other poultry species. Consequently, FSIS invites such establishments to apply to participate in the SIP. To be eligible to participate in the SIP, establishments must now meet all applicable line speed criteria listed below relative to process control and regulatory compliance and submit a waiver request to OPPD for consideration with supporting documentation as outlined below, pertinent to the particular regulation(s) identified in the request to be waived. An FSIS project manager will be assigned to assist the applicant through the review process.
Criteria for FSIS to Consider Line Speed Waivers as Outlined in 83 FR 49048
On February 23, 2018, in the Constituent Update (CU), FSIS announced the criteria that the Agency will use to consider requests from NPIS young chicken slaughter establishments to operate at line speeds of up to 175 bpm and also outlined line speed waiver request submission requirements. As provided in the aforementioned CU and FRN, to be eligible for a line speed waiver, a young chicken establishment:
- Must have been operating under the NPIS for at least one year, during which time it has been in compliance with all NPIS requirements;
- Must be in Salmonella performance standard category 1 or 2 for young chicken carcasses;
- Must have a demonstrated history of regulatory compliance. More specifically, the establishment has not received a public health alert for the last 120 days; has not had an enforcement action as a result of a Food Safety Assessment (FSA) conducted in the last 120 days; and has not been the subject of a public health related enforcement action in the last 120 days; and
- Must be able to demonstrate that the new equipment, technologies, or procedures that allow the establishment to operate at faster line speeds will maintain or improve food safety.
- Must not have not had an NR for violation of GCPs (9 CFR 381.65(b)) in the past 120 days.
- Must conduct and submit daily Aerobic Plate Count (APC) testing and at least weekly Salmonella testing.
In addition to outlining the criteria FSIS will consider to determine whether to grant a line speed waiver, the February 23, 2018 CU also describes the documentation that establishments will need to provide with their waiver request submissions including documentation that:
- Provides details about the establishment’s HACCP system, including how the establishment addresses the inhibition and reduction of Salmonella;
- Demonstrates that the establishment has effective process control by submitting one year of microbial data, methodology for evaluating that microbial data (e.g., indicator organism data in a process control chart identifying upper and lower control limits), correlation of that microbial data to the establishment’s sanitary dressing process control data, correlation of that microbial data to FSIS’s Salmonella data, and interventions to address seasonality;
- Describes how existing or new equipment, technologies, or procedures will allow for the operation at a faster line speed (e.g., descriptions or names of the equipment, line configuration, and verification activities that will be used);
- Provides support on how the increased line speed will not negatively impact FSIS employee safety nor interfere with inspection procedures (e.g., information about safety protocols or line configuration);
- Supports how the modifications to its food safety system to operate at the faster line speed will maintain or improve food safety (e.g., a statement that explains how the new equipment will provide the same as or cleaner evisceration processes, or how an improved line configuration will continue to prevent cross contamination); and
- Indicates the type of records that will be maintained in the new process, including the collection of information that will assist FSIS in performing appropriate rule-making analysis (e.g., laboratory results, weekly or monthly summary production reports, or evaluations from inspection program personnel).
Because FSIS intends to use the data collected from young chicken establishments to evaluate their ability to maintain process control at higher line speeds, the CU explained that the Agency will limit the additional line speed waivers to establishments that have the ability and intend to operate at line speeds higher than 140 bpm.
Requests to participate in the SIP should be submitted through AskFSIS. If a submitter requires assistance with submission, AskFSIS RIMS can be reached at 1-800-233-3935 (select option 5)
To further assist those interested in participating in the SIP, FSIS Compliance Guideline: Procedures for New Technology Notifications and Protocols, is available on our website.
 The February 23, 2018, Constituent Update is available.
 This refers to a public health alert issued through the Public Health Information System for non-compliance with public health regulations (see FSIS Notice 15-08, Public Health Regulations and Alerts for Use in Determining Inspection Program Personnel Actions and Public Health Risk Evaluation Scheduling in Meat and Poultry Establishments (March 20, 2018)).
- Current Participant List (PDF)