How does an inspector decide what refereed journal articles are satisfactory scientific documentation?(9-03)

Inspection program personnel are not appropriately trained to distinguish between refereed journal articles. As a rule of thumb, all refereed articles are considered scientifically valid. Inspection program personnel do have the responsibility to ensure that the establishment is applying the parameters in the article and that the parameters are met in the establishment.

When EIAO evaluates the design of a HACCP system, when does the CSI have responsibility to question the plan?(9-03)

The CSI has the responsibility to observe the establishment’s HACCP plan as frequently as necessary to remain familiar with the contents and verify that the regulatory requirements of 9 CFR 417 are being met. Anytime the CSI questions the contents of the HACCP plan, he or she should verify that the establishment has supporting documentation for the contents of the HACCP plan, as required in 9 CFR 417.5(a). If the questions revolve around the validity or design of the establishment’s hazard analysis/HACCP plan, then the EIAO, who has received training specific to the evaluation of those issues, should be contacted through supervisory channels.

What is the chain of command/responsibility as far as EIAOs and compliance?(9-03)

The EIAOs are part of the district office staff, under the Office of Field Operations (OFO). Most of the EIAOs are supervised by the Deputy District Managers, but some are supervised by Frontline Supervisors. Compliance is not in the chain of command for supervision of the EIAOs. Compliance activities are performed by the Office of Program Evaluation, Enforcement and Review (OPEER).

How are CSI and EIAOs trained, and how do we deal with the inconsistencies between agency personnel? Who has the final say? (7-04)

CSIs and EIAOs are trained by attendance in relevant classroom courses such as Food Safety Regulatory Essentials (FSRE) and EIAO training, as directed by the district manager. The district manager and deputy district managers are responsible for supervision of the CSIs and EIAOs. If the appearance of inconsistencies between agency personnel becomes a concern, the District Office should be notified in order for inconsistencies to be appropriately addressed.

Are NRs required to be answered within 24 hours?(7-04)

There is no requirement for the establishment to answer an NR in 24 hours. However it is required that the establishment corrects the noncompliance.

How long should it take for a regulatory response to an appeal?(7-04)

Each appeal situation brings with it varying circumstances and details that would not accommodate a “one time frame fits all situations” with respect to response time requirements. Current instructions to FSIS inspection program personnel that are involved in inspection decision appeals to act on each appeal promptly and professionally. Program employees are asked to obtain all relevant information. To objectively evaluate the findings and decisions made by the inspection personnel, and the information that has been provided by the establishment regarding the appeal. Upon making a decision to modify, accept, or reverse the inspection decision regarding the appeal, the program personnel are to communicate the decision orally or in writing to the establishment management as well as other FSIS program employees involved.

To facilitate the efficient and effective resolution of appeals, FSIS recommends that an establishment’s appeal of an inspection decision or finding be based on legitimate disagreement as to the application of a regulatory provision and the facts supporting the disagreement. When appealing the finding, the establishment should be clear and specific as to what the finding is that they are appealing. The establishment should provide as much supporting information regarding the appeal as possible. Appeals should be directed to the immediate supervisor having jurisdiction over the subject matter of the appeal. FSIS’s response time is pertinent to the quality of information that is presented along with each appeal. Timely appeals by establishments will help ensure that the relevant information regarding each appeal is provided to subsequent FSIS decision makers so that facts can be verified promptly.

When an EIAO challenges a plan that has been reviewed, without challenge by the IIC, and has been used historically to produce safe wholesome product – why are they (EIAOs) not required to have science to backup their challenge? (i.e., held to the same standard as the plant?)(9-05)

There may be any number of reasons why an EIAO may have found deficiencies with an establishment’s food safety system, which were not discovered by the IIC. The deficiencies discovered by the EIAO may be design, scientifically based, etc. The IIC and the EIAO have different roles. The IIC verifies that the establishment is implementing their food safety systems as written. The EIAO does a more in-depth assessment. The EIAO will assess the HACCP, SSOP, pre-requisite programs, and the entire food safety system to determine if they meet regulatory requirements and are supportable. As part of an assessment the EIAO will review supporting documentation, that an establishment maintains for the decisions they have made. This assessment may determine that the supporting documentation may be inadequate for a variety of reasons. The establishment may not be following the documentation, or the documentation may no longer be scientifically valid. The assessment may determine that the hazard analysis made by the establishment may have overlooked a potential food safety hazard.

These may be just a few of the types of deficiencies found on an assessment. If there are specific issues with deficiencies found by an EIAO, those questions need to be addressed with the EIAO or district office.

Why are inspectors required to write NRs as the initial communication of a problem or new issuance?(9-05)

Many plants have periodic meetings with inspectors to go over HACCP, SSOP, and other issues and in these plants, often there is communication that may prevent the noncompliance from occurring and consequently the need for documentation. However, instruction to inspectors is once a non-compliance occurs they are to document the incident.

What are the future plans for collaborative industry training and assistance for smaller plants in food safety assessments?(9-05)

The International HACCP Alliance hosted a meeting in Dallas, TX in December 2005, to develop a strategic plan for improving small and very small establishments’ food safety programs and further protect public health and ensure regulatory compliance. This meeting was attended by academia, industry representatives, extension agents, FSIS officials, FDA and APHIS officials, and State inspection officials. There were several needs identified to improve the agency’s outreach activities. Collaborative industry training and assistance for smaller plants in food safety assessments were 2 things that were part of this discussion. The agency has formed a task force to develop an action plan for FSIS to address the concerns raised at this meeting. This task force is evaluating the best methods of accomplishing these issues while utilizing all of its resources effectively.

What directions are inspectors given about the types and quantities of NRs to write?(7-06)

A NR is to be completed whenever inspection program personnel observe that an establishment has failed to meet one or more regulatory requirements.

Define contamination and adulteration in terms of condensation and what justifies an NR(7-06)

The Sanitation Performance Standards do not require an establishment to be completely “free” of condensation. For example, if condensation is in an area where there is no potential for product adulteration, then this condensation might not create an insanitary condition and therefore there would be no noncompliance. In contrast, noncompliance exists when condensation has formed in locations and to an extent where product has the potential to become contaminated or adulterated (creation of an insanitary condition). If adequate ventilation is not provided to prevent condensation from forming in these areas, or to prevent an insanitary condition, the requirements of 9 CFR 416.2(d) are not being met.

If condensation is acceptable on a piece of equipment cleaned every day, why is it not acceptable on a ceiling that is cleaned everyday as well? (7-06)

For condensation to be “acceptable” certain parameters must be met: 1) the establishment has employed all possible ventilation controls to minimize condensation, 2) the surface is capable of being cleaned and sanitized (e.g. stainless steel), and 3) if formation of condensation on the surface is inevitable, the establishment includes procedures in its Sanitation SOP and implements those procedures to ensure that any condensation which drips onto product or food contact surfaces will not result in product adulteration. Regardless of the overhead surface, FSIS does not allow the presence of condensation which can otherwise be controlled and prevented through ventilation. Inspection program personnel evaluate each occurrence of condensation to determine compliance.

How does industry communicate to FSIS concerns about inspector consistency and quantities of NRs written?(7-06)

Industry may communicate with local inspection personnel and also request a meeting with the Frontline Supervisor (FLS). The district office may also be called and a meeting requested through the District manager.

How long should a food safety assessment take?(7-06)

As stated in the EIAO training material, there is “no timeline for completion” of a food safety assessment. An EIAO may take as long as necessary to assess all aspects of the establishment’s food safety system. The average time to conduct a food safety assessment is 2 weeks. Some factors that influence the length of the assessment are: complexity of the food safety system, amount of records generated by the system, size of the establishment, types and complexity of flaws found within the food safety system, and the number of components associated with the food safety system.

How frequently should food safety assessments be conducted in the same establishment?(7-06)

The agency does not have a specified frequency for conducting FSAs. FSAs may be conducted due to: District Office direction, a Consumer Complaint, foodborne illness, foreign particle contamination, repetitive Lm findings, STEPS Triggered Sample Form, Salmonella Performance Standard failure, or “other” food safety issues.

Who approves the validity of scientific studies during EIAO reviews? (7-06)

The scientific community “approves” the validity of scientific studies published through their journal/publication review process. FSIS does not “approve” or validate scientific studies, however, EIAOs may question how the scientific study is used to support the validity of a specific food safety system.

If EIAOs do not approve scientific information, then why are they asking for it?(7-06)

The EIAO has the responsibility to verify: