If your operation is one of the nation’s more than 6,500 meat, poultry, egg product and other slaughtering or processing plants, or your plant manufactures any of 250,000 different processed meat and poultry products—from hams, sausages, soups and stews, to pizzas, frozen dinners and any items containing specified amounts of cooked poultry or raw meat—chances are good that you will meet one or more of the 7,600 U.S. Department of Agriculture Food Safety and Inspection Service (USDA FSIS) personnel charged with ensuring that your facility is operating in compliance with federal regulations. And, in working with these inspectors, most processors recognize that the agency’s approach to inspection has changed from an old school command-and-control style to a less adversarial process review and risk based assessment approach. The role of the FSIS inspectors, however, has not changed: Their job is to verify on a regular basis that your plant is following its Hazard Analysis and Critical Control Points (HACCP) plans, Sanitation Standard Operating Procedures (SSOPs) and generic E. coli testing plans, including meeting Salmonella performance standards, zero tolerance for Listeria monocytogenes, and requirements for wholesomeness, pest control and economic adulteration.
If deficiencies are found and there are indications that the plant is not meeting regulatory requirements during a plant visit, inspection staff will document these findings on a noncompliance record (NR) and take regulatory control action as needed. NRs are viewed by the agency as valid and effective notice to the establishment that regulatory compliance has not been maintained leading to the control action. The NR defines the specific deficiency and provides the establishment the opportunity to return to a state of regulatory compliance. Multiple or recurring NRs indicate that the establishment is not meeting regulatory requirements.
Owners and operators under a USDA Grant of Inspection have the right to appeal decisions and actions of inspection personnel, including NRs. Appeals are part of due process under the rules of practice detailed in the Pathogen Reduction/HACCP final rule. But even with the agency’s efforts to implement the nonadversarial inspection approach, some establishments are reluctant to appeal NRs for fear of retaliation by FSIS inspectors who may take the appeal as a direct confrontation of their authority. These industry operators take the GAGA approach: Go Along to Get Along. However, the agency has repeatedly emphasized that processors should not fear retaliation when exercising their right to appeal and that threats of retaliation or intimidation by inspectors should be reported as outlined in FSIS Directive 4735.7. Lack of appeals from, or the silence of, a facility indicates that the plant is in agreement with an issued NR, which may give the impression that there is something wrong with its system when in fact there is not, or worse, that the plant is not taking inspection findings seriously. In addition, if further regulatory action is taken by FSIS on the basis of an NR, the establishment cannot appeal the existing NR after the fact. Thus, it is recommended that regulated facilities appeal NRs with which they do not agree, provided they do so judiciously and with adequate support.
Determining when to appeal a noncompliance record requires a good understanding of FSIS’s inspection requirements and approaches, a good understanding of your product and processes, and a good understanding of how to phrase your appeal letter and documents to articulate the areas of dispute and provide evidence as to why the record should be amended.
What are Noncompliance Records?
Under the rules of practice detailed in the Pathogen Reduction/Hazard Analysis and Critical Control Points (HACCP) final rule, FSIS has broad authority to issue regulations and carry out provisions of Federal Meat Inspection Act and the Poultry Products Inspection Act. If an establishment fails to comply with regulatory requirements, FSIS has no ability to determine that products are unadulterated. FSIS may take actions to prevent the production and shipment of suspect product until the establishment can provide assurance of compliance. Regulatory control action by inspection personnel may include product retention, rejection of equipment or facilities and production stoppage. Further actions that may be taken by FSIS include withholding of marks of inspection or suspension of inspection with or without prior notification.
FSIS’s Performance Based Inspection System (PBIS) has two components that guide inspection program employees and their in-plant activities. One of the components of PBIS is the Inspection System Procedures Guide (ISP), which includes all in-plant procedures for FSIS inspectors. The second component is an automated system that schedules the work and incorporates findings from the tasks. The guide also lists all applicable regulatory requirements and agency directives. As inspection program employees conduct inspection and find deviations they will document these findings on FSIS Form 5400-4, Noncompliance Records (Figure 1).
When a plant receives an NR the first action should be to review the document to determine the nature of the deficiency and the action that may be taken. Block 10 of the NR provides a description of the noncompliance issue. It will identify the time of the observation, the item affected and whether product or a product contact zone is involved. FSIS Notice 42-07 further emphasizes that Block 10 should:
• Describe each noncompliance in clear, concise terms, including the exact problem
• Provide an explanation of how FSIS notified the establishment’s management of the noncompliance
• Identify whether any regulatory action has been taken
It is a good idea to conduct an investigation and talk with any employees involved with the inspection finding. This will aid in determining the appropriate response to the NR or whether an appeal is justified. Important areas of the NR to review are the regulations cited, whether the correct section in Block 7 (i.e., “HACCP,” “SSOP” or “Other”) is marked, and if the correct classification indicator in Block 9 (i.e., monitoring, corrective action, recordkeeping, implementation or verification) is identified. The last point is especially important because an incorrect classification indicator entered into the PBIS system can have a bearing on the future intensity of inspection at the establishment. This is especially important now that FSIS is considering a more risk based inspection (RBI) system. Finally, ensure that the NR is dated correctly and is signed by the FSIS inspection program employee.
If, based on the investigation, the determination is made to answer the NR it will be the responsibility of the plant to provide information in both Block 12, Plant Management Response (Immediate Action) and Block 13, Plant Management Response (Further Planned Action[s]). The response in Block 12 provides the plant with an opportunity to identify the actions taken immediately to identify and eliminate the cause of the deviation, that control was regained and that no product injurious to health or otherwise adulterated as result of the deviation enters commerce. It also allows the plant to include detail that may not have been included by the FSIS inspector to provide more clarity to the deficiency, such as size or makeup of residue on food contact surfaces, proximity to product, and so on. Responses should be as complete and as detailed as necessary to clearly present the actions taken by the plant. The response in Block 13 allows the plant to identify any further planned action(s) to prevent reoccurrence of the deficiency or make physical improvements.
As much as it is possible, make sure that the responses are not repetitive or redundant. This may give the impression that the plant is being dismissive of the NR. If repeat responses are necessary, be sure to back them up with the reason why (different equipment, new personnel or procedure) and have the documentation to back it up (for example, sign-in roster of persons trained). Remember, providing a date for further actions is binding and those dates should be met; however, if there is a reason that this date cannot be met (i.e., availability of repair materials or contractor delays), it will be important to notify FSIS that an extension is necessary. It is then vital that the extension date be met. Requesting continuous extentions shows a lack of commitment to addressing issues.
Interestingly, there are no regulations requiring that the plant respond to NRs that they receive, and some plants do not respond because they perceive that any commitments made are binding to FSIS. It is recommended that plants respond as a means of maintaining communication between the firm and FSIS and for the purposes of documenting corrective and preventive actions to have an accurate written account for future reference. Keep in mind that noncompliance records are accessible through the Freedom of Information Act (FOIA) and these have been requested in past by media outlets such as the “main scream media and tabloid TV” shows to fit their agenda. It is best to paint a clear picture in the response that takes away their ammunition.
There is also no time limit for returning NRs; however, a timely response can go a long way in demonstrating the plant’s interest in and commitment to maintaining regulatory compliance. Responses to an NR can be made directly on the form itself or on company letterhead if more space is needed for an adequate response. Plant management should also sign and date the NR when it is returned to FSIS. An NR is considered “open” when the noncompliance still exists and when a response from the manufacturing facility has not been provided. Open NRs are reviewed daily by inspection program employees. The form will be filed as “closed” when the establishment has brought itself into compliance with regulatory requirements and the inspector has verified the actions taken. The weekly meeting between plant management and FSIS inspection provides the company an excellent opportunity to discuss findings and actions, open NRs or unresolved issues.
Linking NRs: A Trend to Watch
If repeat deficiencies with the same apparent root cause are found by inspection they will begin to “link” NRs. Linking NRs provides notice to the establishment that the list of “further planned action(s)” is not effective in preventing the specific deficiency. If the deficiency trend continues and repeated NRs are linked there will be justification for FSIS to take further enforcement action.
There are four general indicators that the FSIS inspector is linking NRs:
• Identification in the document of prior and similar NR(s) and date(s)
• A description in the NR of the further planned action that was ineffective in preventing reoccurrence
• A discussion of the trend at the weekly meeting with plant officials
• A statement in Block 10 of the NR that continued failure to meet regulatory requirements can lead to enforcement action per 9 CFR 500.4.
Plant management must be alert for the development of trends in NRs and take action to ensure control measures are sufficient to prevent a reoccurrence of the noncompliance. Failure to recognize and deal with trends can lead to additional regulatory actions including a food safety assessment conducted by FSIS Enforcement Investigations Analyst Officers (EIAOs).
Drafting an Appropriate Appeal
There may be good reasons to appeal NRs or portions of the NR if there are discrepancies. Examples of good reasons to appeal NRs include; the deficiency was already being addressed by the plant when the inspector noticed it, the documentation is questionable, the NR is for non-amenable product (unless this product can have a negative impact on amenable product), the Inspection System Procedure (ISP) code is misapplied or incorrect noncompliance classification. Clerical errors or regulatory reference errors can be appealed but this will typically result in the NR being revised to reflect corrections, not the NR being rescinded.
There are also bad reasons for making an appeal and these frivolous actions should be avoided. It is not a good idea to appeal NRs just because you have the right to, if you recognize that the situation was actually worse than what is documented, because you believe the inspector was only “technically” correct, or if you cannot handle the potential consequences of denial of the appeal.
Appeals do not have to be made in writing. Some plants will discuss the NR and present a verbal appeal to the inspector as a means of maintaining communication. A verbal appeal also may be beneficial in situations in which product has limited shelf life and time is critical. It is highly recommended that the appeal be presented in a written format, even after a verbal appeal is made, as this provides a record of the appeal and the opportunity to more clearly state the position of disagreement with the NR or portion of the NR. There is no time limit on submitting appeals but the best approach is to submit them as soon as possible so that events and details are still fresh in the minds of those involved, particularly if there is follow-up discussion between the plant and inspection personnel.
Typically, the appeal process follows the USDA Office of Field Operations (OFO) chain of command, starting with the inspection program employee that issued the NR. Establishments can progressively appeal up the chain, beyond plant inspection to the agency’s Front Line Supervisor (FLS) followed by the District Manager (DM), Executive Associate for Regulatory Operations (EARO), OFO Assistant Administrator, and finally, to the FSIS Administrator. As you can see, you can appeal an NR all the way to Washington if local and district level decisions are not satisfactory.
Once the appeal is presented to the appropriate FSIS program employee, he or she will document the appeal in FSIS 5.1.3, evaluate the documentation and provide a written response, usually within two to five days. If the appeal is granted the program employee will change the parts of the NR that have been challenged or will delete the NR if the entire record has been challenged. Additionally, if the NR had been linked, the linkage will also be deleted. If the appeal is denied, the plant will have the opportunity to continue the appeal process up the chain of command. Response time at each level may take longer; up to two weeks at the FLS level and around 30 days at the DM level or higher. If the appeal time appears to be taking longer than expected it is a good idea to follow up with a call just to verify that it has not been lost in the shuffle.
The format and content of the appeal is extremely important, and while there is no standard format, each plant should develop one that works for them. The objective of the appeal format it to explain why the NR is inaccurate (i.e., the deficiency did not occur, the NR is based on supposition and not fact, it is coded incorrectly, there is no regulatory justification, etc.) by focusing on the issues and facts. It should be written objectively and in a non-personalized tone to show respect and professional courtesy. One format that appears to be effective is as follows:
1. An opening sentence that includes the number and date assigned by FSIS to the NR, and notification of the establishment’s intent to appeal.
2. A brief paragraph describing the NR and the deficiency noted.
3. A paragraph that specifically identifies the reason why the deficiency did not occur or is inaccurate and why it is being appealed. It is a good idea to cite scientific documents, employee interviews or in-plant procedures and best practices since the rationale must support the decision to appeal.
4. A statement asking FSIS to provide a clearly written statement as to why the condition listed in the NR is in direct violation of regulatory requirements.
5. A closing paragraph that expresses appreciation for the agency’s consideration in reviewing your documentation and the expectation that the appeal will be upheld by FSIS.
6. A signature by an authorized plant employee.
Appealing Examples of NR Response Letters
The following are actual examples of NRs received by USDA inspected plants, the appeals that were subsequently presented to FSIS and the results of those appeals. The name of the Consumer Safety Inspector (CSI), Rusty Hinges, has been created to conceal the identity of the establishment.
Case 1. The NR from CSI Rusty Hinges indicated that the type of noncompliance was food safety. The CSI checked Box 7, HACCP Plan, entered “03G01” in Box 8, ISP Code, which indicates that a HACCP verification procedure was not performed, and cited “HACCP–Monitoring” in Box 9, Noncompliance Classification. Box 10, Description of Noncompliance, read as follows:
“While performing inspection of the grinding room operations the following noncompliant condition was noted at 23:00 hours. Cases of raw beef were being opened in preparation for grinding. When one of the cases was opened I was standing directly beside the operator and noticed an unpleasant smell. The plant employee noticed the smell as well. The employee left the area and returned with the Lead who instructed the grinding employee to segregate all boxes with off odor. I told the Lead at the time that I was retaining the product to prevent usage. The present HACCP plan for Fully Cooked Not Shelf Stable product does not have a CCP for the grinding step of the process.”
When the NR was received, the plant reviewed its elements, conducted interviews with all involved employees, and concluded that there was justification for an appeal based upon the actions of the grinding room personnel. Here is the plant’s appeal to FSIS:
To: CSI Rusty Hinges
RE: NR #0001
We are appealing the above cited Noncompliance Record due to the fact that we at the plant were not given an opportunity to follow our evaluation process before the meat was retained by USDA. By the CSI’s own words, “The employee opening the case noted the smell as well. Employee left the area and then immediately returned with the Lead who identified himself as the production lead. I told the lead at that time that I was retaining this product to prevent usage and to be certain it was under control.” The grinding room employee was following the internal plant Standard Operating Procedure (SOP) (copy attached), which is to notify his lead of any findings of questionable or off condition meat. The lead would decide the disposition of the meat or contact his supervisor if he required more guidance. Quality Assurance becomes involved if there are still more questions, but all plant employees have the authority to place questionable product (or equipment) on HOLD during the decision period. Before the lead was given the opportunity to perform the next step of our training instructions, the CSI had already taken control of the meat. At no time were our employees asked what the disposition of the meat in question was, nor the actions they would take.
In the denial letter from the CSI, the CSI mentions FSIS regulation 417.2, Hazard Analysis and HACCP Plan. We have had a HACCP plan since 1999 which includes written and dated procedures for all food safety hazards (CCPs) identified in the plan. We have determined that there are no biological or chemical hazards at the grinding step based on historical and scientific data. The biological hazards associated with raw meat and poultry, specifically pathogens E. coli O157:H7, Salmonella and Listeria monocytogenes, are addressed later in the HACCP plan, at our scientifically validated cooking step. Off condition of meat from spoilage organisms typically caused by yeasts, lactic bacteria, and Aeromonas are not pathogens based on numerous scientific reports and information from a foremost accredited authority on microbiological research; therefore, this should not be considered an unforeseen hazard.
The CSI also states that there are no Quality Assurance personnel available on Sunday nights. This is not relevant to the handling of this issue as Quality Assurance management is available by phone if and when their assistance is required during these hours. We want to re-emphasize that the production personnel present have the authority to segregate questionable ingredients. However, before they were able to exercise their authority, the CSI intervened without determining first whether or not the plant was going to take control.
The question that should be asked and answered is “If the CSI were not present, would this meat have reached the consumer?” We contend that even in the absence of the CSI, had we been allowed to follow our protocol, this meat would not have been ground nor would it have been used in production. It is our contention that the grinding room employee was following his instructions by notifying the lead and they would have taken control action had the inspector not been present or had she not taken control action.
Our reason for challenging this noncompliance record is that we disagree that there was a deviation of our HACCP plan and that the inspector’s actions pre-empted our process of taking control action. Therefore, we ask you review this appeal and rescind the Noncompliance Record, based on the fact that the CSI took control of the product, not giving the plant an opportunity to follow protocol. If you have further questions, please don’t hesitate to contact me.
The outcome of this appeal to the CSI? It was denied. However, a further appeal to the FLS was upheld because the plant took action as prescribed in the SSOP that was preempted by the CSI’s control action.
Case 2. The NR from CSI Rusty Hinges indicated that the Type of Noncompliance was “Other–Consumer Protection,” Box 7 cited “Other,” Box 8, ISP Code was identified as “04B04” (product is accurately labeled and ingredients are not properly identified), and the Noncompliance Classification in Box 9 indicated “Product–Misbranding.” Box 10, Description of Noncompliance read as follows:
“While performing inspection of the finished product packaging operations the following noncompliant condition was noted at 0845 hours. One pallet of Sausage, Egg and Cheese Burrito product had been placed on plant QA Hold. The indication on the Hold tag indicated that the product inside was actually Ham, Egg and Cheese Burritos. When I inquired of the Lead what had happened to this product she responded that they had pulled the wrong roll of box labels from the warehouse. However, during a routine QA check the error had been discovered and only one pallet of product had been packed with the wrong label. The lead indicated that it was to be re-boxed later in the shift with the correct label. I informed the lead that the product was misbranded and that I was retaining the product to prevent it from entering commerce.”
When the NR was received the plant reviewed the elements, conducted interviews with all involved employees, and concluded that there was justification for an appeal based upon the actions by the plant’s Quality Assurance Department. Here is the plant formatted appeal to FSIS:
To: CSI Rusty Hinges
RE: NR #0002
We are appealing the above cited Noncompliance Record due to the fact that the product in question had been identified by plant Quality Assurance as mislabeled and control of the product had been taken by the application of the QA Hold tag. The plant had already determined that corrective action was required and in the CSI’s own words “the lead indicated that it was to be re-boxed later in the shift with the correct label”. The plant actions were sufficient to ensure that misbranded/mislabeled product would not enter commerce.
We ask you review this appeal and rescind the Noncompliance Record, based on the fact that the plant had already identified the noncompliance and took control action before the CSI had become aware of the labeling error. We appreciate the opportunity to present our appeal and expect that the NR will be rescinded based on the actions taken by the plant. Otherwise, we request that you provide a clearly written statement as to why the condition listed in the NR is in direct violation of regulatory requirements. If you have further questions, please don’t hesitate to contact me.
Here again, the outcome of the appeal to the CSI was that it was denied because the CSI believed that they needed to take control of the product. However, on further appeal to the FLS the appeal was upheld. The FLS determined that because the plant’s QA department took action to control the mislabeled product and to prevent it from entering commerce there was no regulatory noncompliance.
An Appeal to Industry
Since the implementation of HACCP and SSOP regulations, all food plants operating under the USDA FSIS regulatory inspection framework have a greater understanding of their responsibilities to manufacture safe and wholesome foods—products that are not adulterated or manufactured in an environment that can result in adulteration. Along with ensuring that the plant’s food safety programs and systems conform to regulatory requirements, meat and poultry establishments are also obligated to participate in the effective application of those rules and guidelines. Maintaining open and honest communication of differences of opinion through direct communication, without fear of reprisal, is one means of developing a solid and respectful relationship with regulatory personnel. In addition, whether the outcome of an appeal is that the NR is rewritten, the appeal is denied or the appeal is upheld, it is important for plant owners and operators understand their rights to appeal and exercise it judiciously. This is an “appeal” to industry to stand up for itself when justified.
Michael M. Cramer is Director, Quality Assurance with Windsor Foods, a family of companies making a range of Italian, Pan-Asian, and Southwestern style appetizers, entrées, pastas and ready-to-eat items for foodservice, national accounts and retail industries. He has more than 30 years’ experience in the food industry and recently authored the book, Food Plant Sanitation: Design, Maintenance and Good Manufacturing Practices. Cramer is a former Director with the National Meat Association, a professional member of the Institute of Food Technologists, a member of the International Association for Food Protection and serves on the Editorial Advisory Board for Food Safety Magazine.
Robert A. Savage, President of HACCP Consulting Group, has more than 35 years’ experience in the food industry, including positions as director of microbiology for the Great Atlantic and Pacific Tea Co., and several positions with both the U.S. Food and Drug Administration and USDA FSIS. While with FDA, he was active in the implementation of the first HACCP-based low-acid canned food regulations, investigations of botulism outbreaks, product recalls and evaluations and audits of firms’ compliance with FDA regulations, both domestically and overseas. At FSIS, Savage was responsible for the development of the HACCP-based canning regulations for meat and poultry products and served as the agency’s representative on a six-member HACCP Special Team to study how the model could be used in the meat and poultry industry and in inspection. Savage was awarded the 2000 Professional of the Year Award from the National Meat Association, where he serves on the board of directors. He is accredited as a lead instructor by the International HACCP Alliance.
Michelle Walker is Process Control Supervisor for Windsor Foods. She has more than 20 years’ experience working in the Quality Assurance Department at the company’s Riverside, CA processing plant, and currently spearheads food safety training programs for Windsor. A HACCP-certified professional, Walker also responds to USDA NRs issued to the plant, working with appropriate departments to address these documents. She holds a food microbiology degree from the University of Iowa.