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FSIS Waiver of Regulatory Requirements

We evaluated the policies and procedures FSIS used to waive regulatory requirements and allow establishments, including those participating in SIP, to test new procedures, equipment, and meat and poultry processing techniques.

Audit Report: 24601-0007-31
Published: 03/26/2021
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Fast Facts

The Food Safety and Inspection Service (FSIS) is the public health agency within the Department of Agriculture (USDA) responsible for ensuring the Nation’s commercial supply of meat, poultry, and processed egg products is safe, wholesome, and accurately labeled and packaged. FSIS is tasked with reducing contamination and limiting illnesses through the regulation of agricultural food products and is empowered to inspect all meat, poultry, and processed egg products through several acts: the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, and select sections of the Agricultural Marketing Act.

FSIS helps prevent foodborne illness by performing food safety inspection activities at more than 6,000 establishments nationwide, ensuring that inspections align with existing and emerging risks, and maximizing domestic and international compliance with food safety policies. The agency also helps ensure safety through a series of policies and regulations that define how establishments can operate to produce a safe and wholesome product. Through these efforts, FSIS has mandated that establishments have a Hazard Analysis and Critical Control Point (HACCP) plan. FSIS deploys over 8,000 inspection program personnel to these establishments to ensure that policies, regulations, and approved HACCP plans are followed and working as intended in the production of safe and wholesome meat, poultry, and processed egg products.

Salmonella Initiative Program

In 2008, FSIS designed and implemented the Salmonella Initiative Program (SIP) to benefit public health by encouraging slaughter establishments to test for microbial organisms in their products and take corrective actions to maintain process control, thereby minimizing the presence of harmful pathogens in the Nation’s food supply. The program works to minimize microbial pathogens in food products by offering incentives to meat and poultry slaughter establishments to control Salmonella in their operations. FSIS grants waivers of certain regulatory requirements with the condition that establishments participate in SIP. Under SIP, establishments are required to test for Salmonella and other microbial organisms and share all sample results with FSIS. The FSIS Administrator has the authority to waive, for limited periods, provisions of certain regulations for meat and poultry establishments. One purpose of the waiver authority is to permit experimentation so that new procedures, equipment, or processing techniques may be tested to facilitate definite improvements in the slaughter, processing, and packaging of meat and poultry products. Meat and poultry slaughter establishments that wish to obtain a waiver from the regulation that prescribe slaughter line speeds must participate in SIP as a condition of the waiver.

After FSIS receives a line speed waiver request from an establishment, the agency is required to
follow the procedures in FSIS Directive 5020.2, The New Technology Review Process
(Oct. 24, 2017), to verify that the establishment meets the 12 line speed waiver criteria and to
evaluate its waiver request submission. The criteria FSIS uses to assess the various waiver
requests differ depending on the type of waiver the establishment requests.

Waiver Process

Within FSIS, the Office of Policy and Program Development is responsible for coordinating the evaluation and approval of waiver requests. In order to approve a waiver, the FSIS Office of Policy and Program Development appoints a project manager to oversee a Technical Review Team (TRT) as part of the waiver review process. The TRT reviews and analyzes data and information from the requesting establishment to support the waiver request and reports their findings to the project manager. The project manager is responsible for ensuring an establishment’s request for a waiver has met the necessary 12 line speed waiver criteria before forwarding a decision memorandum to upper management for concurrence and signature. Before making the determination for approval or denial, the project manager ensures the establishment has adequately shown it has met the 12 line speed waiver criteria listed in the Federal Register. For instance, the staff from FSIS’ Public Health Science (i.e., microbiologists, chemists, and toxicologists) assesses the adequacy of any scientific information, the proposed study or protocols, and methods used in the waiver request. The staff also ensures the information in the request is consistent with Code of Federal Regulation requirements.

The TRT is also tasked with evaluating those waiver criteria that require a more comprehensive review of the materials submitted by an establishment. For example, the team examines an establishment’s ability to maintain process control and its capability to operate at line speeds above 140 birds per minute (bpm). The project manager gathers all of the establishment-provided information for the waiver and the TRT’s analyses, reviews it for completeness, evaluates whether the 12 line speed waiver criteria have been met, and then documents their conclusions regarding whether to approve the waiver. The project manager puts their recommendation for approval or denial into a decision memorandum and sends it to upper management. FSIS management will send a formal letter outlining the approval or denial of a line speed waiver to the establishment. If approved, the waiver will be in place until a plant either demonstrates it cannot consistently meet the conditions of its waiver agreement or until FSIS finalizes the line speed regulation. Lastly, the project manager uses the FootPrints system to store slaughter establishment information, documents, and communications related to their oversight work on the waiver request.

New Poultry Inspection System Waivers

The New Poultry Inspection System (NPIS), which was established in 2014, is the latest inspection system for young chicken and all turkey slaughter establishments. One of the criteria for young chicken establishments to be eligible for a line speed waiver is that the establishment must have been operating under the NPIS for at least 1 year. In addition to meeting the line speed waiver criteria, NPIS young chicken establishments must also participate in SIP. This system allows establishments and FSIS to reconfigure certain aspects of poultry inspection, such as shifting agency resources so FSIS inspectors can perform more offline inspection activities, and the opportunity to increase the maximum bpm line speed. Participation in SIP allows establishments to request a line speed waiver to move from a maximum of 140 bpm to 175 bpm. However, before an establishment can request a waiver for increased line speed, it has to demonstrate that it meets all of the line speed waiver criteria outlined in the Federal Register, including consistent process control, meaning the establishment demonstrated that it consistently minimized the presence of pathogens of public health concern. As of December 2019, 36 of the 47 SIP waivers (76 percent) were NPIS line speed waivers.

On March 20, 2020, FSIS stopped accepting additional requests for SIP poultry slaughter line speed waivers while the agency considers transitioning from the use of waivers to amending the current maximum line speed of 140 bpm set by regulation. FSIS analyzed the data collectedrelated to line speed and started the rulemaking process.

 

OBJECTIVE

Our objectives were to evaluate the policies and procedures FSIS used to waive certain regulations that allow establishments to test new procedures, equipment, and processing techniques, including establishments participating in SIP.

WHAT OIG FOUND

The Food Safety and Inspection Service (FSIS) helps prevent foodborne illness by performing food safety inspection activities at more than 6,000 establishments nationwide, ensuring that inspections align with existing and emerging risks, and maximizing domestic and international compliance with food safety policies. The agency also helps ensure safety through a series of policies and regulations that define how establishments can operate to produce a safe and wholesome product. The Salmonella Initiative Program (SIP) offers incentives to meat and poultry slaughter establishments to control Salmonella in their operations. Specifically, the program grants waivers of certain regulatory requirements with the condition that establishments test for Salmonella and other foodborne illnesses and share all sample results with FSIS.

While FSIS project managers did receive adequate documentation to make their overall waiver assessment conclusions, we found they did not adequately document their analysis of the information used to support their decisions regarding line speed waivers and did not consistently use the FootPrints system for maintaining records. This occurred because FSIS procedures did not always contain the level of detail necessary to ensure FSIS project managers follow a consistent method to document and upload their assessments of the supporting information. Furthermore, project managers found FootPrints difficult to use. If FSIS does not have ready access to the documentation and analysis used to support waiver decisions, the waiver process loses transparency and diminishes confidence in the FSIS protocol.

FSIS concurred with our recommendations and we accepted management decision on both recommendations.