Why doesn’t FSIS accept the validity of case studies as the medical field does?(9-03)

The establishment may utilize any appropriate documentation for support as long as it is scientifically valid (e.g., peer reviewed), and the parameters of the research are applicable to the establishment’s process. 9 CFR 417.4(a) requires initial validation of the HACCP plan and ongoing verification activities to demonstrate that the HACCP plan is effective in controlling the identified hazards, and that the establishment is able to meet the conditions specified.

Has FSIS changed stance on stabilization of cured, smoked intact pork muscle product? (9-03)

FSIS has not changed its position on stabilization of cured, smoked intact pork muscle product. Establishments have the responsibility to address any food safety hazards likely to occur in the process. If an establishment is applying heat to product, it is expected that any food safety hazards associated with the stabilization of that product are addressed. If an establishment determines that Clostridium perfringens is a food safety hazard likely to occur, measures that are adequate to control this hazard must be an integral part of the HACCP system. FSIS has permitted establishments to use the criteria in FSIS Directive 7110.3 or Appendix B, Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization), as supporting documentation for stabilization processes. Establishments should understand that the criteria in FSIS Directive 7110.3 may not be the most effective measures for controlling spore-forming bacteria. Establishments may use other stabilization criteria provided that they have valid support for the effectiveness of those criteria for controlling the appropriate microbiological hazards.

What is expected in validation of lethality and calibration of cook processes?(7-04)

It is expected that the establishment shall validate the lethality cook process, in accordance with 9 CFR 417.4(a), if that process is part of the HACCP plan.

The validation of cook processes for the lethality of identified pathogens of concern should demonstrate that an appropriate reduction of the pathogens and their toxins or toxic metabolites has been achieved. This validation can be developed by the establishment or its process authorities by using information obtained from literature or by comparing their methods with established processes and guidance material.

For the destruction of significant microbiological hazards, it is expected that the establishment will control the cooking process and ensure that the finished product is in compliance with the critical limits that have been established to control the significant hazards. Ongoing calibration of process-monitoring instruments used in the cook process is a vital component in providing this assurance and is a regulatory requirement found in 9 CFR 417.4(a)(2)(i). Documents supporting the ongoing calibration verification procedure and the frequency of that procedure are required to be maintained, per 9 CFR 417.5(a)(2).

Are facilities allowed to use Agency Guidance materials as justification for CCPs and sampling frequency?(7-04)

Generally, the use of compliance guidelines which are Agency issuances provided to assist plant management during the development of their food safety systems, are acceptable reference documents. The following link, via the FSIS homepage, lists all available guidelines. http://www.fsis.usda.gov/regulations_&_policies/Compliance_Guides_Index/index.asp

Is Appendix A an adequate reference for RTE? – Beef/Pork; Poultry; Dry/Semi Dry(7-04)

Yes, Appendix A can be used for these types of products as long as the establishment is assured the guideline is controlling hazards identified within the hazard analysis for their specific products. In addition, all parameters within the guideline must be met.

Where in FSIS are small and very small FSIS plants supposed to go to get assistance on scientific support?(7-04)

Establishments may contact the Strategic Initiatives, Partnerships and Outreach Staff (SIPO) for copies of FSIS documents at the following link: www.fsis.usda.gov/about_fsis/opaeo/index.asp

Can we use process control for moisture CCP and Aw as validation?(7-04)

We are not aware of a process that is using process control as a CCP for moisture. It is difficult to determine what you will be using as a critical limit for this plan. The Aw might be used for validation purposes but we are not sure how you are correlating water activity with the process control. Ultimately, you will need to provide support for this type of process.

What are the expectations for slaughter plants concerning chemical residues?(7-04)

The FSIS expectations for Slaughter plants concerning chemical residues are that the establishments will fully address chemical residues in a HACCP environment and meet the requirements of 9 CFR 417.2. The establishment has to conduct a hazard analysis to determine the food safety hazards reasonably likely to occur in the process and it has to identify preventive measures to control those hazards. Food safety hazards are those hazards which have previously occurred or those that are likely to occur. In the Federal Register: November 28, 2000 (Volume 65, Number 229), FSIS published Residue Control in a HACCP Environment. This Federal Register is a good source of information on FSIS’s expectations, and it also contains the “Best Available Practices” which is the best preventive practices available to slaughters. These practices include:
1) ensuring all animals brought into the establishment for slaughter are identified so they can be traced back to the producer,
2) notifying animal producers in writing of both violative and high non violative residue levels,
3) exploring the possibilities of certified residue avoidance programs,
4) exploring the possibilities for live animal testing.

What type of scientific verification will be expected from small and very small establishments for RTE alternatives?(9-05)

a. Would challenge studies from large companies be considered?

Yes, providing that the processing method and the species are the same.

b. If so – is there a mechanism by which this can be facilitated?

There is no program or mechanism by which large companies would voluntarily share data with smaller companies, if that is the question. The studies and data developed by large companies become a support document for that company’s decisions and are considered proprietary information. If the data could be taken out of the context of supporting documentation and shared with the public, it would be up to the company that owns the data. Presently, to our knowledge there is no public or private sector organization that is facilitating the sharing of data. Also, since the data are usually developed to meet the originating company’s specific needs, it is unknown as to how useful such data would be to other companies.

What is the current policy for documentation for hazard analysis decisions? ie: historical information, modeling, plant generated data, challenge studies, journal articles, university research, etc. (9-05)

The Agency policy for documentation for the hazard analysis decisions has not changed. The regulation in 9 CFR Section 417.5(a)(1) requires that an establishment maintain records that include all supporting documentation associated with the written hazard analysis. This documentation can include as you suggest a variety of different sources, as well as statements related to the decisions or conclusions recorded in the hazard analysis.

- Is supporting documentation required for every “none identified” response given in a hazard analysis?

9 CFR 417.5(a)(1) requires an establishment to maintain the written hazard analysis including all supporting documentation. The supporting documentation required by these regulations must support all decisions made during the hazard analysis. If the establishment has identified no hazard at a particular step in the process, it should have a basis for its conclusion and should be able to support why a “none identified” response is recorded in the hazard analysis. This decision may just be a statement of the facts that leads them to the conclusion that no further consideration is needed at that step in the process under that type of hazard.

What is the policy concerning 90% humidity during cooking (notice 43-05)?(9-05)

The relative humidity (RH) provisions in Appendix A for cooked, roast, and corned beef (e.g. 90% RH for the entire process; 90% RH for at least 50% of the cooking time but in no case less than 1 hour) apply only to those processes in which the surface moisture of the product can evaporate, and surface drying can occur prior to destruction of the microorganisms. Such processes include the production of meat and poultry jerky and roasts.

For certain other processes, the RH is not significant because the humidity around the product is inherently maintained, and moisture does not have to be added. These processes include but are not limited to: