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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
Pathogen Reduction/HACCP &
HACCP Implementation
September 20, 2000
The purpose of this document is to provide guidance for the supervisory oversight of the Sanitation Performance Standards discussed in FSIS Directive 11,000.1 to front line supervisors (e.g., Circuit Supervisors, Multi-IPPS Supervisors, Supervisory Veterinary Medical Officers, and Supervisory Food Inspectors).
It is important for inspection personnel to be consistent in their efforts to verify that establishments are complying with the Sanitation Performance Standards. The front line supervisor is in the best position to ensure consistency and uniformity. The purpose of this guideline is to provide the front line supervisor with a tool that can be used to assure consistent and uniform application of inspection relative to the Sanitation Performance Standards.
Supervisors have a key leadership role in ensuring that inspection personnel are consistent and uniform in their efforts to verify that establishments are complying with the Sanitation Performance Standards. This leadership role is defined by the Supervisory Blueprint, which was introduced as a tool for leading change. The Supervisory Blueprint illustrates how front line supervisors are expected to perform in the HACCP environment.
The Blueprint contains six roles and three foundation principles. The six roles are:
The three foundation principles are:
While carrying out these roles described by the Supervisory Blueprint, supervisors are to work "on" the system rather than "in" the system in a proactive way rather than a reactive manner. This guide describes how supervisors can apply the roles and foundation principles outlined in the Supervisory Blueprint to work "on" the system proactively overseeing the implementation of the Sanitation Performance Standards. It outlines what front line supervisors need to be looking for, questions to raise, and issues to address when conducting IPPS visits. (Note: The Appendix contains a Supervisor's Checklist that shows the link between supervisory oversight of the Sanitation Performance Standards and the front line supervisor's job performance standards.)
The Performance Based Inspection System (PBIS) is a tool for front line supervisors to utilize in conducting IPPS visits. PBIS data is useful to help ensure consistent and effective delivery of inspection and the effective use of resources. PBIS uses quantifiable data to generate reports of inspection results. Some reports are produced directly from the PBIS system. Other reports are supplied to Districts electronically by the Technical Service Center. Supervisors can rapidly scan activities, elements, and procedures to identify trends in inspection application and plant compliance. Front line supervisors should pay particular attention to procedures coded as "not performed," trends in noncompliance, and unscheduled procedures. This information will help the supervisor prepare for IPPS visits, and can indicate areas for correlation.
The sanitation requirements for official meat and poultry establishments were revised to be consistent with the PR/HACCP regulation by incorporating performance standards into §416. Performance standards are results-oriented, allowing for new ways of achieving the specified results. In other words, the results to be achieved are defined, but the means or methods to be used to achieve the results are not specified. Performance standards are not subject to multiple interpretations. Although establishments can use different and varying means to meet the performance standards, the required results are always the same – establishments must operate under sanitary conditions in a manner that ensures that product is not adulterated, and that does not interfere with FSIS inspection and its enforcement of such standards.
The issuance of the Sanitation Performance Standards regulation involved canceling various Notices, Directives, Bulletins, etc. The abolition of regulations requiring the prior-approval of various systems and activities by FSIS personnel places the responsibility for these systems and activities on the establishment. Establishments must account for the safety and appropriate use of their systems and activities. They also have the flexibility to determine and use what is appropriate and sufficient for maintaining sanitary conditions and preventing the adulteration of product. FSIS inspection personnel are responsible for verifying that the plant's systems and activities meet the Sanitation Performance Standards. Specific instructions are found in FSIS Directive 11,000.1.
The Sanitation Performance Standards regulation interacts with the HACCP and SSOP regulations in that it addresses the manner in which establishments must be operated and maintained to prevent the creation of insanitary conditions, thereby ensuring that insanitary conditions are not created, and that product is not adulterated. When establishments fail to meet the Sanitation Performance Standards, inspection personnel must evaluate what is known for a fact, and to determine if the establishment has also failed to meet HACCP and/or SSOP requirements. More detail about the interaction between the Sanitation Performance Standards, SSOP, and HACCP requirements is provided in the following sections of this guideline.
This section outlines guidance to front line supervisors when conducting IPPS visits with regard to what to look for, questions to raise, and issues to address regarding the inspection methods related to the Sanitation Performance Standards regulation.
Circuit Supervisors should communicate with inspection personnel to ensure that they understand that the overall general rule of the regulation is that the establishment must prevent the creation of insanitary conditions to ensure that product is not adulterated. This rule should be helpful in making determinations about noncompliance. Front line supervisors should engage in dialog to answer the questions that inspection personnel have about what is and what is not "insanitary," and what constitutes "adulteration." These two terms are defined in Section 301 of the regulations.
Supervisors should also ensure that inspection personnel understand the linkage between the Sanitation Performance Standards and the establishment's HACCP plan and SSOP. For example, if direct product adulteration is found while conducting the 06D01 procedure (i.e., for requirements such as 416.2(b), (d), (e), (g), 416.3, 416.4, and 416.5), the noncompliance relates to either the HACCP (03) and/or SSOP (01) requirements. In this case, documentation on NRs should reflect the appropriate 01 or 03 procedure, and enforcement should follow the appropriate section of the Rules of Practice.
When reviewing NRs in the government file, front line supervisors should verify that inspection personnel are aware that the former ISP codes of 06D01 (Facilities and Equipment), 06D03 (Condemned and Inedible), 60E01 (Sewage), 06F01 (Water Certification), 06F02 (Water Requirements), and 06G01 ( Pest and Rodent Control) have been combined into one ISP Code: 06D01, "Sanitation Performance Standards." The change was necessary because the previous codes were based on former prescriptive regulations.
Finally, supervisors should verify that inspection personnel are randomly verifying the different sections of 416.2-416.5. This can be determined by reviewing descriptions of noncompliance related to the Sanitation Performance Standards on NRs, and by talking with inspection personnel. Supervisors should also verify that inspectors are aware that if at any time they stumble upon a situation where they suspect any possible noncompliance with any of the Sanitation Performance Standards, they should perform an unscheduled 06D01 procedure.
During plant visits, front line supervisors need to make observations and ask questions to determine whether the methods used by inspection personnel are consistent with the ones outlined in Directive 11,000.1. For example, are inspection personnel reviewing the establishment’s supporting documentation, such as EPA registration? Are they mistakenly requiring the plant to use only those pesticides that have received prior approval? Do inspection personnel understand that the plant's pest control program does not have to be a written one? Do inspection personnel understand that the establishment is responsible for preventing sources of adulteration of product, even if the cause of the adulteration originates from conditions outside the designated boundaries of the establishment? Do inspection personnel understand that product can be adulterated due to the misapplication of pest control products? Are inspection personnel familiar with the EPA requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)? Do they have questions about the application of a pesticide or the safety of a chemical? If questions arise that cannot be answered by the supervisor, the Technical Service Center can provide technical assistance.
When noncompliance is observed, do inspection personnel understand that any one of the following procedures may apply, depending on the situation: 06, 01, and 03? For example, inspection personnel may observe condensation on walls when conducting a 06 procedure. Supervisors should correlate with inspection personnel to make sure that they determine that if it is unlikely that this condensation will directly affect product, the appropriate procedure code to use in documenting the noncompliance is 06D01. However, based on what is known for a fact, if it is likely that the condensation will directly affect product, or if it is determined that the condensation has directly affected product, inspection personnel need to perform the appropriate process 01 and/or 03 procedures. If noncompliance is observed while conducting the 01 or 03 procedures, it should be documented correspondingly.
In order for front line supervisors to determine if the inspection methods are consistent with those outlined in FSIS Directives 11,000.1 and 5000.1, they should discuss observations with inspection personnel. For example, they should observe inspection verification of the condition of the building, walls, ceilings, floors, doors, windows, and areas where both edible and inedible products are processed, handled, and stored. Do inspection personnel understand that prior approval requirements related to facilities and construction have been eliminated? Do inspection personnel know how to access building construction codes if they have questions about the appropriateness of facility design or new construction? Do inspection personnel understand the need for separating edible and inedible product? The supervisor should answer any questions that inspection personnel have about this section of the regulation.
During an in-plant visit, the front line supervisor should correlate with inspection personnel to determine whether or not the lighting is sufficient to examine product, and to monitor and maintain sanitary conditions. Do inspection personnel in poultry establishments understand that FSIS no longer has a specific requirement (e.g., 30-foot candles) for light intensity? Do inspection personnel understand that the requirements for lighting related to inspection and reprocessing stations remain in effect?
Circuit Supervisors should correlate with inspection personnel to determine whether the methods they are using to verify compliance with this section of the regulation are consistent with those outlined in Directive 11,000.1. For example, do inspection personnel understand that it is impossible for establishments to "eliminate" odors, vapors, and condensation? Do they understand that establishments must be held responsible for controlling odors, vapors, and condensation so that they do not create insanitary conditions or adulterate product? Do inspection personnel understand that if while conducting the 06D01 procedure, they observe insanitary conditions or adulterated product, they need to perform the appropriate 01 and/or 03 procedures and document the noncompliance accordingly?
During plant visits, front line supervisors should determine whether the inspection method provides a means to verify that requirements are met. If the requirements are not met, have inspection personnel documented noncompliance using the appropriate procedure code? If the sewage disposal system is private, do inspection personnel understand what documentation the plant is required to have on hand and how to access it? Do inspection personnel understand that prior approval of sewage and waste disposal systems has been eliminated? In addition, supervisors should ensure that inspection personnel understand the linkage between the Sanitation Performance Standards and the establishment's HACCP plan and SSOP. For example, if waste disposal results in direct product adulteration, instead of 06D01, this noncompliance relates to HACCP (03) and/or SSOP (01) requirements. Documentation on the NR should reflect the appropriate 01 or 03 procedure, and enforcement should follow the appropriate section of the Rules of Practice.
While conducting an IPPS review, the front line supervisor should verify that inspection personnel have determined that the establishment has adequate documentation of water potability. Are inspection personnel familiar with the National Primary Drinking Water regulations? Are they familiar with the technical information that is required to document water potability (e.g., coliform counts)? If water pressure is insufficient to maintain sanitary conditions, is this documented appropriately on an NR by inspection personnel? Do inspection personnel understand that the establishment is able to reuse water in a manner that will not adulterate product nor create insanitary conditions (e.g., add chlorine to recirculating water in a chill tank for raw poultry to reduce pathogens; use water treated by an advanced wastewater treatment system to wash equipment or raw product if followed by a potable water rinse; use nonpotable water to wash floors or equipment in areas where edible product is not handled)? Are inspection personnel verifying that establishments are documenting and monitoring their water reuse activities in either their HACCP or SSOP plans as required? Supervisors should verify that inspection personnel understand that water that comes into contact with product must be pathogen free. Instead of 06D01, this noncompliance relates to SSOP (01) or HACCP (03) requirements. Documentation on the NR should reflect the appropriate 01 or 03 procedure, and enforcement should follow the appropriate section of the Rules of Practice.
During a plant visit, the supervisor should observe inspector assessment of dressing rooms and lavatory facilities and discuss observations with inspection personnel. In particular, identify any discrepancies in determinations and discuss them to ensure consistency within the circuit. For example, if insanitary conditions are observed, are they documented on an NR by inspection personnel? Are inspection personnel aware that the prescriptive requirements specifying the number of facilities in an establishment have been eliminated? Are inspection personnel aware that official meat and poultry establishments are governed by OSHA regulations concerning toilet facilities? Do they understand that for this reason, FSIS has removed its provision requiring separate lavatories and toilet facilities for each sex? Supervisors should verify that inspection personnel understand that if at any time when verifying compliance with procedure 06D01, the conditions in dressing rooms or lavatories are such that product may become adulterated (e.g., toilet overflowing into the processing area), instead of 06D01, this noncompliance relates to SSOP (01) requirements. Documentation on the NR should reflect the appropriate 01 procedure.
During IPPS visits, the Circuit Supervisors should ensure that inspection personnel are verifying that the plant meets the requirements related to sanitation of equipment and utensils. The supervisor should also ascertain whether inspection personnel understand that these requirements will be verified the majority of the time through the performance of the SSOP procedures codes 01B and 01C. For example, are equipment and utensils used for processing or to otherwise handle edible product or ingredients maintained in a sanitary manner? Are equipment or utensils constructed, located, or operated in a manner that allows FSIS personnel access to inspect them and to determine whether they are sanitary? Are receptacles for storing inedible materials marked in a conspicuous and distinct manner?
In addition, supervisors should ensure that inspection personnel understand the linkage between the Sanitation Performance Standards and the establishment's SSOP and HACCP plan. If, for example, equipment is operated in a manner that results in direct product adulteration, instead of 06D01, this noncompliance relates to SSOP (01). Documentation on the NR should reflect the appropriate 01 procedure, and enforcement should follow the appropriate section of the Rules of Practice.
Supervisors should verify that inspection personnel understand and apply the appropriate methods for verifying that sanitary operations are maintained as specified in 11,000.1. The supervisor should ascertain whether inspection personnel understand that these requirements will be verified the majority of the time through the performance of the SSOP procedures codes 01B and 01C. For example, are all food and non-food contact surfaces cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions or the adulteration of product? Do inspection personnel have questions about what the appropriate frequency for cleaning and sanitizing should be? If so, do they understand what to do if they have such questions (i.e., review plant documentation, confer with the Technical Service Center)? Are cleaning compounds, sanitizing agents, processing aids, and other chemicals used by the establishment handled and stored in a manner that will not create insanitary conditions or adulterate product? Is the plant protecting product from adulteration during storage, loading, and unloading at and during transportation? If there is evidence that insanitary conditions are being created, or that product is being adulterated, are inspection personnel documenting the noncompliance appropriately on NRs (i.e., writing a full and complete description of conditions and using the appropriate procedure codes and trend indicators)? Have inspection personnel verified the "paperwork" for chemical compounds? Do inspection personnel understand and utilize the linkage between the 06D01 procedure and process 01 procedures in cases where direct product contamination or adulteration occur?
Supervisors should reiterate that FSIS employees must follow or exceed the establishment’s protocol for personal hygienic practices. Do inspection personnel understand that they have the authority to take action against any unhygienic practice that could result in insanitary conditions or adulterated product? Supervisors should verify that inspection personnel understand that if at any time when verifying compliance with procedure 06D01, employee practices are such that product may become adulterated, instead of 06D01, this noncompliance relates to SSOP (01) requirements. Documentation on the NR should reflect the appropriate 01 procedure, and enforcement should follow the appropriate section of the Rules of Practice.
Supervisors should correlate with inspection personnel to ensure that inspection personnel understand when it is and when it is not appropriate to take regulatory control action (e.g., tagging equipment, utensils, rooms or compartments). It is appropriate to take regulatory control action, which may include tagging affected areas, when an official establishment operates in a manner that leads to insanitary conditions or product adulteration. Documentation on the NR should reflect the appropriate procedure code and trend indicator. The regulatory control action should remain in effect until the establishment has taken corrective action and has proposed effective preventive measures.
While conducting IPPS visits, supervisors should verify that inspection personnel are aware that there are guideline documents available to establishments electronically on the FSIS internet homepage. These documents are also available in a public Outlook folder called, "Sanitation Performance Standards Compliance Guide." The purpose of this guide is to provide establishments with assistance to meet the Sanitation Performance Standards. The guide presents references or methods that have historically proven to be effective in maintaining sanitary conditions in meat and poultry establishments, such as past FSIS regulations and guidance, recommendations from the 1999 Food Code, and other technical sources. Supervisors should verify that inspection personnel understand that, in general, establishments following the guidance can be fairly certain they are meeting the Sanitation Performance Standards. However, since each processing environment is unique, in some cases the methods presented may be inadequate to ensure sanitary conditions or to prevent the adulteration of meat and poultry products. In addition, supervisors should verify that inspection personnel understand that the information contained in the compliance guidance is non-regulatory in nature, and therefore it is not appropriate to take any type of enforcement action if the plant fails to comply with the methods or references contained in the guide. Supervisors should ensure that inspection personnel understand that regardless of the compliance guidelines, establishments have the flexibility and the responsibility to determine and use methods that are sufficient and appropriate for maintaining sanitary conditions and preventing product adulteration.
Supervisors should determine whether inspection personnel are making appropriate, logical judgments in determining whether a noncompliance situation exists. The standard to communicate in general is the overall rule that the establishment must prevent the creation of insanitary conditions to ensure that product is not contaminated or adulterated.
In addition, inspection personnel should be directed to consider what is known for a fact, and what is reasonable to conclude in making determinations regarding noncompliance. Supervisors can direct inspectors to contact the Technical Service Center in cases where they feel uncertain or have technical questions about whether or not noncompliance exists. Although the Technical Service Center will not provide "the answer" to inspection personnel, they can help them develop a thought process that will be useful in making noncompliance determinations.
In addition, front line supervisors should correlate with inspection personnel during IPPS visits with regard to the following issues related to regulatory decision making.
Front line supervisors should verify that inspectors understand that, when SSOP noncompliance occurs, the plant's response must comply with 416.15. Supervisors should verify that if inspectors have questions about the adequacy of a plant's response (i.e., immediate or further planned actions) they have the option of contacting the TSC to get technical guidance on factors to consider in making regulatory determinations.
Supervisors should ensure that inspection personnel are evaluating trend indicators over time to determine whether to take regulatory action based on the establishment's performance. Observation and documentation of repetitive noncompliance with the same root cause demonstrates either design failures or ineffective execution of the establishment’s overall sanitation procedures/program. Supervisors must assess from inspection records that inspection personnel are determining whether a trend of noncompliance that warrants the withholding of inspection is occurring by:
- compiling all the NRs related to Sanitation Performance Standards in question.
- verifying that these NRs indicate that the establishment has repeatedly failed to meet Sanitation Performance Standards and has detailed that they have not successfully implemented corrective and preventive measures.
Supervisors should correlate with inspection personnel to ensure that documentation of establishment's noncompliance with regulatory requirements is done in a consistent and uniform manner. This will involve reviewing the NRs in the government file, observing plant conditions, and talking with inspection personnel. Following is an overview of issues that front line supervisors should include in correlations with inspection personnel when conducting IPPS visits.
Verify that when noncompliance with Sanitation Performance Standards is observed, it is documented appropriately on an NR. Supervisors should verify that inspectors are aware that they should not be allowing the plant to address the issue without documenting the incident. Supervisors should emphasize the importance of documentation of repetitive noncompliance when such repetitive noncompliance reflects failure to implement previous corrective and preventive actions with the Sanitation Performance Standards. Effective enforcement action is predicated on the documentation of repetitive noncompliance which details specific failure of previous corrective action.
Supervisors must discern whether documentation of the noncompliance creates a clear and accurate description of the incident. It is important that the NR be written in a manner to allow "visualization" of the noncompliance. Following is a set of criteria that can be applied to documentation with regard to any type of noncompliance.
If the same noncompliance was documented previously, does the narrative state specifically what, with regard to the previous corrective and/or preventive actions, failed?
Verify that the NR contains a detailed description of the plant's response (i.e., immediate and further planned action). Ensure that inspection personnel understand that it is ideal when the plant provides a written response. However, the plant is not required to respond in writing and should not be forced to do so by inspection personnel. Verify that when the plant does not provide their immediate and further planned action in writing, the inspector is recording the plant's actions on the NR.
Verify that inspection personnel understand how to document noncompliance with SSOP or HACCP requirements that are discovered while conducting a sanitation performance standard procedure. For example, ensure that inspection personnel understand that if while conducting an 06D01 procedure, conditions are such that they lead an inspector to determine that product is directly contaminated or adulterated, but it is not a food safety concern (e.g., edible grease, food-grade hydraulic fluid), inspection personnel follow the instructions found in FSIS Directive 5,000.1, for SSOP noncompliance. Likewise, verify that inspection personnel understand that if while conducting an 06D01 procedure, conditions are such that they lead an inspector to determine that product is directly contaminated or adulterated, and there is a food safety concern, inspection personnel follow the instructions found in FSIS Directive 5,000.1 for HACCP noncompliance. Finally, verify that inspectors understand that if they observe noncompliance with regard to the sanitation performance standards, but there is no direct product adulteration or contamination, and product contamination or adulteration is highly unlikely, the noncompliance relates to the appropriate sanitation performance standard.
Supervisors should verify that inspection personnel who find noncompliance with more than one regulatory requirement (e.g., Sanitation Performance Standards and SSOP or HACCP) understand how to document the noncompliance. Verify that the description on the NR covers all noncompliances observed. Ensure that the trend indicator on the NR reflects SSOP or HACCP noncompliance (as directed in the 8 day HACCP training program in modules 9B and C).
Supervisors should be proactive by working on the system, correlating with inspection personnel on enforcement methodology and procedures during IPPS visits to ensure that inspection personnel understand the requirements and how to apply them correctly. During this correlation, supervisors should ensure that inspection personnel understand that effective enforcement recognizes the appropriate balance between the plant's right to do business and the government's responsibility to protect the public. Supervisors should also verify that inspection personnel understand that the successful execution of any interim or sustained enforcement actions must be based upon sound and competent utilization of the noncompliance identification, description, trend indicator classification, and documentation process, including scientifically credible and legally supportable evidence.
Supervisors should correlate with inspection personnel to verify that they are aware of when it is appropriate to take regulatory control actions, such as tagging product, equipment, or facilities, and when it is not appropriate to do so. For example, inspectors should not tag an area in the facility where noncompliance with the Sanitation Performance Standard occurs when it clearly has no potential to directly affect product. However, when product is directly contaminated, and the contamination does not pose a food safety hazard, inspection personnel should notify the establishment and retain (i.e., tag) the affected product. The affected product should be retained until the inspector can assess the plant's response to ensure that it effectively addresses §416.15 (corrective actions). The noncompliance should be documented using the appropriate SSOP procedure code. If product is directly adulterated, and it poses a food safety hazard, and the hazard is one that the establishment has addressed in it's HACCP plan (e.g., with critical limits), inspection personnel should notify the establishment but should not retain the affected product at this point. Instead, inspection personnel should allow the establishment to implement corrective actions with regard to the noncompliance. If, in the inspector's judgment the corrective actions are inadequate (i.e., do not effectively address all four provisions of §417.3), the inspector should take official control action to prevent adulterated product from entering commerce. If the establishment has not addressed the food safety hazard in its HACCP plan, the inspector should verify that the requirements of 417.3(b) were met. As always, if the plant takes action such that adulterated product is about to enter commerce, inspection personnel should take official control action to prevent it from occurring.
In addition, supervisors should verify that inspection personnel understand that withholding, suspension, or withdrawal of inspection are enforcement processes that will be based upon a determination that a system has failed, not upon individual occurrences of deficiencies. These actions are subject to Department and Agency supplementary guidelines and Rules of Practice (§500.1 –500.8). Supervisors should correlate with inspection personnel to ensure that they are familiar with the Rules of Practice. Inspection personnel should be aware that there are some conditions for which it is appropriate to provide notice to the establishment before withholding or suspending inspection, and there are conditions for which no prior notification is required.
No prior notification is required before withholding or suspending inspection when any of the following conditions occur:
Inspection personnel should be aware that the Agency is required to provide prior notification of withholding or suspension actions to establishments for the following conditions:
Supervisors need to determine whether inspection personnel are effectively monitoring plants that have been subject to enforcement actions. This includes ensuring that plants are implementing the corrective actions that placed a suspension in abeyance. Inspection personnel need to understand that if the plant fails to implement their corrective actions effectively, or if the corrective actions fail to resolve the condition that resulted in the suspension, that the suspension can be reinstated. Supervisors should ensure that inspection personnel understand that they should communicate regularly with the District Office when conducting this type of monitoring activity.
CHECKLIST RELATED TO THE SUPERVISOR’S JOB PERFORMANCE STANDARDS
The following checklist has been developed to ensure accountability for frontline supervisors who are responsible for ensuring that inspection personnel are consistent in their efforts to verify that establishments are complying with the Sanitation Performance Standards. This checklists links the responsibilities of the frontline supervisor to job related performance standards.
Performance Element 1 - Manages, Implements, and Correlates Program and Organizational Culture Changes
Performance Element 2 - Establishes and Maintains Inspection Standards and Monitors Activities
Performance Element 3 - Manages and Evaluates Personnel
Performance Element 4 - Representation and Working Relationships
SUMMARY OF REQUIREMENTS RELATED TO SANITATION FROM OTHER FEDERAL AGENCIES
Environmental Protection Agency (EPA)
Food and Drug Administration (FDA)
Occupational Health and Safety Administration (OSHA)
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