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| IKE Scenario 04-06: Clarification of the Appeal Process for FSIS Personnel and Industry(Example: Appeal Denied)
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Objective: Objective: To provide clarification of the appeal process for FSIS personnel and Industry (Example: Appeal Denied).
You are a GS-9 relief inspector detailed to a very small processing establishment that produces beef and poultry products. Tuesday morning, you perform a scheduled 03B01 procedure. You review the current HACCP plan as well as records pertaining to verification activities generated during the previous production day. You observe an omitted recordkeeping entry (i.e. no result entered) that is required as part of CFR 417.5(a)(3). You inform the plant manager that a Noncompliance Record (NR) will be issued. You document the recordkeeping noncompliance into PBIS and provide the plant manager with the NR prior to leaving the establishment.
Three days later, plant management requests a meeting to discuss the recordkeeping noncompliance NR. You are aware that the appeal process, addressed in 9 CFR 306.5 and 381.35 affords industry the right to appeal the regulatory decisions of program employees. Because this NR relates to a poultry product, you are also aware that the Agency has determined that FSIS will accept appeals from plant management after the 48 hours cited in 9 CFR 381.35, to be consistent with the appeals procedure cited in 9 CFR 306.5. In addition, you are aware the establishment's appeal of the program employee's decision can be made directly to the inspector that issued the NR, instead of being made to the inspectors' immediate supervisor.
FSIS policy is the appeal can be verbal or written and should be made without the fear of retaliation or intimidation by program personnel. In addition, you know that appeals need to be handled promptly and in a professional manner. You must evaluate the establishment's appeal based on the inspection findings and the application of the regulatory provisions as well as any additional information the establishment provides to support its position, and to address each point raised by the establishment.
In your meeting with plant management, the plant manager requests that the NR be removed from the PBIS system, and provides a written letter that presents her reason. The HACCP record has the required signature, time and date, and identifies a record review verification activity was performed at the frequency required.
During the discussion, you inform the plant manager that you appreciate her timely appeal request. This allows the facts and observations to be provided to subsequent decision makers to be verified, if necessary. You conclude the meeting by acknowledging her concerns and you advise her that you will provide a written response to her appeal after considering the information she provided in her appeal.
You conduct an evaluation of the establishment's reason for their appeal, your inspection findings, and also review the pertinent regulatory provisions to support your decision. You prepare a written response in which you affirm that a regulatory noncompliance did exist. In your written response, to support your decision to deny the appeal, you address the regulatory requirements as well as addressing the issue that was raised by the plant manager. You describe in detail the part of the cited regulation that the plant manager may not have fully implemented. The regulation requires that a verification procedure(s) include the result of the activity, and be documented in the official record. You also enter the appeal information into PBIS.
That afternoon during your discussion with the plant manager, you provide the written appeal response and also advise plant management of their right to further appeal the issue(s) to the next level in the FSIS "chain of command", which is the Frontline Supervisor (FLS). You then outline the chain and explain it as the immediate supervisor of the program employee making the decision which generally is as follows:
1. Program employee who made the determination.
2. PHV IIC or Mini-Circuit Supervisor.
3. Frontline Supervisor.
4. District Manager.
5. Executive Associate of Regulatory Operations.
6. Deputy Assistant or Assistant or Office of the Assistant Administrator for Field
Operations.
7. Administrator
You further advise plant management that it is FSIS policy where fresh or other time sensitive product is being held pending an appeal, that a timely response to the appeal will be provided.
You follow up by explaining that whenever an appeal is denied at one level of supervision, the establishment may elect to present its written appeal to the next level in the FSIS chain-of-command. You emphasize when plant management forwards an appeal they should include all the information they have to substantiate the appeal as well as including all previous appeal responses by the different levels of the agency regarding the specifics the appeal.
On Friday, the plant management provides a written appeal to the FLS, reiterating the original basis for the appeal. In addition, the plant manager states that she believes she is in compliance with the regulations because of the fact that she followed the generic HACCP plan verbatim and used other material she found on the FSIS website. She also indicates that her signature on the record means that her review of the record was acceptable and that she does not feel she needed to record a result.
After conducting an in-depth analysis and discussions with the relief inspector, the FLS determines that the appeal should be denied. In the discussion with the relief CSI, the FLS emphasizes that FSIS personnel should view the appeal process as an industry due process right that often results in better understanding of the regulatory requirements by all parties.
In the FLS written response, to support his decision to deny the appeal, the FLS addresses the regulatory requirements, in addition to addressing each issue raised by the plant manager:
- To comply with the regulatory recordkeeping requirements associated with 9 CFR 417.4 (a)(2)(iii), the official HACCP record must comply with 417.5 (a)(3) and 417.5 (b). The employee conducting the verification activity of a records review, failed to enter the "results" of the verification activity conducted.
- The generic HACCP material, as stated in the introduction of the document, can be used as a starting point for developing a specific HACCP plan, and is guidance material not to be used "as is" to meet all the regulatory requirements.
The FLS provides the written response to the plant manager informing her that the NR appeal was denied based on the information provided and the regulatory requirement, and provides a courtesy copy to the relief inspector to be placed into the government office file.
The FLS informs the plant manager during their discussion, that she has the right to appeal his decision following the FSIS Supervisory chain of command.
As a result of the thorough discussion with the FLS and CSI, and the timely written appeal response, the plant manager has a better understanding of the reasons that the NR was issued and accepts the noncompliance as documented. The FLS then enters the necessary information into PBIS to complete the appeal process.
For IKE related questions, send e-mail toIke@fsis.usda.gov. For technical or regulatory questions, send e-mail to
TechCenter@fsis.usda.gov
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Last Modified: Apr 20, 2006 |
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