We are pleased that Dr. Michael Fisher has joined the FTCLDF website as a regular contributor. Dr. Fisher is a retired United States Department of Agriculture (USDA) Food Safety and Inspection Services (FSIS) veterinarian, bringing decades of experience enforcing FSIS regulations during the slaughter and processing of animals for which the USDA provides inspection services. Dr. Fisher is thrilled to bring you his expertise and guidance to help you navigate regulatory compliance. His goal is for small, USDA-inspected meat processors to succeed and to understand how to best maintain compliance and reduce regulatory issues.
In our house is a large container of LEGOs. Over the years, my grandchildren built all kinds of objects from those basic building blocks. Some of those objects had a purpose; others were pure imagination. A noncompliance record (sometimes referred to as “NR” below) is the basic building block for FSIS enforcement actions. Like my grandchildren’s LEGO objects, some noncompliance records have purpose; others are pure imagination.
The Noncompliance Record
FSIS generates and stores noncompliance records in its Public Health Information System (PHIS), which automates the noncompliance record creation process for in-plant personnel (IPP) inspectors. IPP document information in “blocks” that make up the noncompliance record form. Based on the assigned inspection task, PHIS front loads Block 6 with potential “Relevant Regulations.” Based on the “Relevant Regulations” selected, PHIS front loads Block 6a with “Associated NR” matching the relevant regulations selected. Based on the “Associated NR” selected, IPP can copy and paste the “Description of Noncompliance” from an “Associated NR” into a new NR Block 10.
FSIS management performs no quality control on noncompliance records entered into PHIS and presumes that noncompliance records are accurate as written by IPP. In the absence of an appeal, FSIS assumes that the official establishment agrees that the noncompliance record is valid. This approach to noncompliance record creation encourages IPP to select all “Relevant Regulations” and link all “Associated NR” in lieu of determining relevance; and to copy and paste descriptions of past noncompliance in lieu of clear, concise descriptions of the noncompliance as it exists.
These presumptions bear negatively upon the establishment because it creates a flawed compliance history. FSIS can and does use this flawed compliance history to support a withholding action, notice of intended enforcement, suspension, or withdrawal of inspection. If you accept your PHIS compliance history as accurate, do nothing; but do not complain when FSIS implements an enforcement action. If not: Act!
When to Appeal
An official establishment should consider an appeal whenever the establishment believes that Block 6 cites irrelevant regulations, Block 6a makes an incorrect linkage, and/or Block 10 includes incorrect facts or omits significant facts.
It is best to appeal a noncompliance record while events are fresh in your mind. However, per FSIS Directive 13,000.3, there is no timeframe in which FSIS requires an appeal to be submitted for consideration.
How to Appeal
FSIS requires that official establishments submit an appeal to the immediate supervisor of the IPP creating the noncompliance record or the immediate supervisor of the FSIS employee denying the current appeal.
An appeal can be verbal or written. That said, it is an FSIS tenet that, “If it is not written down, it did not happen.” A verbal appeal is no appeal. Appeals need to be written. Appeals submitted via US Mail get lost in the administrative bureaucracy. Appeals submitted via email get lost in the USDA information technology systems. Submitting an appeal via PHIS is the best option. The Federal Records Act [44 USC 3101 et seq] requires FSIS to maintain all information in PHIS as public record. FSIS can neither lose nor deny the existence of an appeal submitted via PHIS. If you do not have an FSIS PHIS account, get one. Instructions are on page 4 in the PHIS Establishment Management User Guide.
To succeed, an appeal must (1) refute the Block 10 narrative and (2) demonstrate compliance with the “Relevant Regulations.”
- To refute the Block 10 narrative, you must clearly and concisely describe why the Block 10 narrative, as written, does not describe failure to meet the performance standard described in the “Relevant Regulations” cited.
- To demonstrate compliance with the “Relevant Regulations” cited, you must provide factual evidence of compliance.
- Documents are required to demonstrate compliance with written plans requirements (i.e., hazard analyses, Hazard Analysis and Critical Control Points [HACCP] plans, Sanitation Standard Operating Procedures, Specified Risk Materials, supporting documents, etc.).
- Records are required to demonstrate compliance with implementation requirements applicable to monitoring, on-going verification, corrective action, etc.
- Imagery is required to demonstrate sanitation compliance. Yes, imagery. The only way to demonstrate that product was not “prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health” [9 CFR 301.2] is with imagery. Take pictures.
- Test results may be required to prove the product is not adulterated.
Give factual reasons why you are correct, backed up by documents, records, and imagery. Do not waste your effort in arguments about why IPP are wrong. Remember, FSIS management presumes that noncompliance records are accurate as written by IPP.
Address only those parts of the noncompliance record you dispute. Do not acknowledge agreement with factual information in the noncompliance record because FSIS can interpret agreement with any part of a noncompliance record as agreement with all parts of the noncompliance record.
Clearly, state what action you want FSIS to take in response to your appeal. If you want the entire noncompliance record deleted, say so. If you want part of the noncompliance record amended or deleted, say so. If you request nothing, FSIS will do nothing.
What to Expect
PHIS automatically sends the appeal to the immediate supervisor at the district level and below. The Supervisory Public Health Veterinarian, Front Line Supervisor, and District Manager can ignore the appeal. They cannot hide from it; it is a public record. Appeals to the Executive Associate for Regional Operations, Office of Field Operations Associate Administrator, and FSIS Administrator can be uploaded into PHIS but not submitted via PHIS. Emailing and requesting an email receipt is the best course of action. You can also upload into PHIS copies of any email and receipt; remember, PHIS is public record. FSIS cannot hide from the public record.
FSIS Directive 13,300.3 instructs supervisors and managers to respond and suggests response time frames. Do not expect a response within these time frames. If you cannot elicit a response after the time frame expires, you can elevate the appeal to the next person in the supervisory chain.
FSIS is required to respond to an appeal, not grant an appeal, no matter how convincing. Do not expect FSIS to grant your appeal right away. If you persist, and if you are right on the public record, FSIS tends to change its behavior. Do not expect FSIS to admit error, ever. If you exhaust the FSIS appeal process (i.e., the FSIS Administrator denies your appeal) you can request a hearing and a decision by a neutral judge in the United States District Court for the District of Columbia [5 USC 701 et seq]. The filing fee is $400.
Sometimes my youngest grandchildren asked for help dismantling their creations. Noncompliance record and enforcement actions work the same way. Sometimes you need help.
As always, if you have a question, please use the Contact Us link and ask.
Did you miss Dr. Fisher’s previous posts?
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