Frequently Asked Questions

Allergens

What are some changes expected in the near future concerning allergens? (9-05)
- Beyond the big 8, what else might we see?

FSIS has issued FSIS Notice 45-05 to increase awareness of plant and inspector responsibilities regarding allergens. This notice mentions the eight major categories of allergens, and Q&As were issued to further explain FSIS policy and to provide guidance to plants considering allergens as a potential hazard. FSIS policy regarding allergens is not new, but FDA's Food Allergen Labeling and Consumer Protection Act (FALCPA) brought renewed attention allergens. One feature of the FALCPA law which only affects FDA regulated products is the law's requirement for "plain English" labeling of allergens. The rationale is that if presented under common names, allergens are more likely to be recognized by individuals affected. FSIS is in the process of developing a proposed rule to provide for the same type of "plain English" labeling as provided for in the FALCPA for meat, poultry, and egg products under the jurisdiction of FSIS. Until the rulemaking is completed, FSIS will permit, but not require, voluntary allergens labeling in concert with the 2002 Allergens Voluntary Labeling Statements policy at www.fsis.usda.gov/OPPDE/larc/Ingredients/Allergens.htm

Food Defense Q

When will security assessments become mandatory?(9-05)

Conducting a security assessment specifically to determine if an establishment has developed a security plan, is not a regulatory requirement. There are no plans at this time to make such plans mandatory. - Are there grants available to improve security for plants? At this point, this office is not aware of any federal or USDA grants that may be available to federal establishments to improve their security system. However, plant management could contact/present this question to their Congressman or Senator and they might know if there are any security grants available through their office or at the state level. I have included a link to a Homeland Security website that addresses specific food/agriculture security grants and how funds are to be dispersed. www.nasda-hq.org/joint/06-06-2002HR3448.htm

NR / APPEALS / FSIS Personnel

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:
That the scientific and/or technical materials are available,
That they provide a scientific and/or technical basis for the identified CCP and CL, and
That the scientific and/or technical data is implemented as described to support decision making in the hazard analysis.

What is the current policy on condensation and has it changed?(9-03)

The current agency policy on condensation has not changed. That policy is expressed in the Sanitation Performance Standard regulations. One section of these regulations (9CFR 416.2(d)) states: "Ventilation adequate to control odors, vapors, and condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions must be provided."

a. Especially over direct product contact area

Condensation directly over a product contact area has the potential to contaminate product surfaces or product if it is not controlled. Since the condensation could adulterate product, condensation above product contact surfaces creates an insanitary condition. This does not meet the requirement of 9 CFR 416.2(d).

b. If condensation is not contributing to mircroflora of raw product is it still considered a hazard, likely to occur?

FSIS has not determined condensation to be a food safety hazard likely to occur in these circumstances.

SSOP

What are the expectations for preventive measures for random hit and misses of pre-op SSOP failures? Are they required to be implemented and documented within 24 hours?(7-04)

When an establishment finds food contact surfaces that are unacceptable during its pre-op monitoring, or when FSIS finds contamination on food contact surfaces while performing a pre-op verification procedure, preventive measures must be implemented. The sanitation records must be available to FSIS inspectors by the start of the same shift the following day. If FSIS finds the noncompliance, inspection program personnel are taught to reject the equipment until the establishment has given preventive measures.

How does finding a positive E. coli O157:H7 indicate an inadequate HACCP plan for raw grinding operation?(9-03)

One E. coli O157:H7 positive result, in and of itself, does not indicate an inadequate HACCP plan. It does indicate that there is a food safety hazard in the product represented by the sample. The HACCP regulations (9 CFR, Part 417) require that the HACCP plan be designed to prevent, eliminate, or reduce to an acceptable level all identified food safety hazards. A positive E. coli O157:H7 result indicates that the HACCP system was not effective in preventing, eliminating, or reducing to acceptable levels that hazard in that part of production.

a. Why does the grinder have to reassess in that situation?

Whether a grinder is required to reassess its HACCP systems or not depends on the situation. If the grinder determined that E. coli O157:H7 is not a food safety hazard likely to occur and receives a positive result, a reassessment is required under the provisions of 9 CFR 417.3(b)(4) as part of the corrective actions to determine if the unforeseen hazard should be incorporated into the HACCP plan. If the grinder has considered E. coli O157:H7 to be a food safety hazard that is reasonably likely to occur, reassessment is not specifically required by 9 CFR 417.3(a). However, as the establishment identifies the cause of the E. coli O157:H7 contamination, and implements measures to prevent recurrence, it may be appropriate in some cases to include a reassessment of all or part of the HACCP plan in the corrective action process.

Industry understanding that agency will only test if the plant has the opportunity to hold the product.(7-04)

The determinations of whether to hold product, and of how much product to hold, is up to the establishment. FSIS directs inspection personnel to notify the official establishment that FSIS will be collecting a sample and to provide enough time to allow the establishment to hold any product that the establishment feels may be affected by a positive sample result.

Can we correlate MPR and Aw? (7-04)

Yes. MPR and aw are related, but the relationship is very product formulation specific. One can easily establish a correlation between MPR and aw for a given formulated product by determining the moisture and protein content of the product and comparing that ratio to the determined aw. However, if you change the product formula, such as adding sugar or changing the salt content, you would not change the MPR, but could significantly change the aw of the product. The aw of the product is a measure of the amount of available water in the product. Any product ingredient that can influence the availability of water, such as solutes (salt, sugars, etc), and starches, etc, will have an effect on the water activity. Certain proteins (vegetable proteins, hydrolyzed proteins, milk, egg, etc) can also have a significant effect on aw, as well as the protein content. Therefore, the relationship of MPR to aw is significantly affected by the product formulation.

How can a grinder prevent being in a recall, because of an E. coli O157:H7 positive at another plant using the same lot of raw materials?(7-04)

A grinder that wants to prevent being in a recall because of an E. coli O157:H7 positive at another plant that used raw materials from the same lot of product must have a means of justifying that the sub-lot is not affected by the positive result at the other establishment. This justification could be provided by the grinding establishment having, for example, a testing program that provides high statistical confidence contamination will be detected or by other means.

Salmonella Reassessment (in poultry slaughter)(9-05)
a. What are the goals?
b. Is it just fact finding?

FSIS is concerned about the recent upward trend in Salmonella positive test results in the poultry industry. The goals of the food safety assessments in poultry slaughter operations are to determine whether the establishments have identified Salmonella as a food safety hazard and to verify that the food safety systems are designed to control these organisms.

Listeria Sampling(9-05)
a. What is the direction of the new intensified sampling?

The Intensified Verification Testing (IVT) program (for cause) has not been altered. There will be the introduction of a new Routine Lm Risk-based (RLm) sampling program within the next few months. It involves a verification testing program of the food contact surfaces, environmental (non-food contact) surfaces, and intact product. Only FSIS personnel that have completed the IVT training will be performing this testing.

b. What is the agency's position on giving plants adequate notification for USDA environmental/product sampling to minimize overall business impact?

FSIS will issue a directive to inspection program personnel that provides them with directions for giving plant management adequate notification to allow the establishment to hold all product represented by the samples.

c.What results are coming in?

The list for conducting the Routine Lm Risk-based Food Contact, Environmental (Non-food contact), and Intact Product Testing "shakedown" phase one included 13 plants from different districts. The results were not made public, but positives were reported from FCS and environmental sites. A report was requested on the results and lessons learned through the trial phase of RLm testing to be included in the preamble of the Lm final rule. The final rule is in the clearance process.

d.What kind of training do inspectors have for sampling? What are future training plans?

The EIAO or PHV will be responsible for the sample collection. They have received formal IVT training delivered through the Center for Learning, College Station, TX

Are there grants available for small companies for sampling?(9-05)

No, FSIS does not have authority to issue these type of personal use grants. FSIS is authorized to use cooperative agreements to reflect a relationship between FSIS and other Federal agencies, States, or cooperators to carry out educational programs or special studies to improve the safety of the nation's food supply. FSIS will engage in cooperative projects that will achieve measurable enhancement of the Nation's public health through food safety.

Is there policy for plants to use government sampled test results?(9-05)

Currently there is no FSIS policy preventing an establishment from using Agency test results However, these data tend to be very limited and might not be adequate to address the establishment's needs. The decisions made by plants within their food safety systems often need specific documentation not available in government sampling results.

There are many sources of data to support decisions that are available from academic and other organizations and resources available to plants. Information and help is available from FSIS Small/Very Small Plant Outreach at the following site: www.fsis.usda.gov/Science/Small_Very_Small_Plant_Outreach/index.asp

Is FSIS going to be doing new Routine Lm risk-based sampling this year?(7-06)

Yes, Routine Lm risk-based sampling has already been implemented.

How many plants will be sampled and how are these plants selected? (7-06)

Approximately one plant per district per month, based on risk. Plants are selected randomly, but plant history can also be factored into the frequency of testing for an individual plant.

When running heat treated product after fully cooked product, if the fully cooked product were to test positive (e.g., for E. coli, Salmonella, or L. monocytogenes), would subsequent heat treated product be affected even though it is not fully cooked?(7-06)

Post-lethality exposed ready-to-eat (RTE) product is adulterated if it passes over a Lm positive food contact surface. The establishment should address this situation through hazard analysis to decide whether the cooking instructions for the not fully cooked product are adequate, or if the pathogen load might be too high for the cooking instruction provided.

As a raw ground beef processor, how can I be sure that the raw beef I receive with a COA is E. coli O157:H7 free? And that product received with a fully cooked COA is Lm free?(7-06)

A Certificate of Analysis (COA) describes quality control data for a particular lot/batch of product. A COA only provides results from a 25 gram sample of the lot/combo to provide information on slaughter plant controls to prevent E. coli O157:H7. However, it does not state that the entire lot is E. coli O157:H7 "free". An establishment must verify in some manner how their purchase specification is being met. This could be by testing the received product at some supportable frequency, or alternatively, the establishment may audit the supplier to see that their supplier interventions are effective in eliminating or reducing this organism to an undetectable level. The same logic applies to L. monocytogenes sampling. However, should the receiving establishment receive "irradiated" product with a COA or "cook-in-bag" product with an accompanying COA, FSIS would then expect these types of products to be E.coli O157:H7 and/or Lm free.

 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/...

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:

  • immersing the product in a liquid cooking medium;
  • cooking product in a sealed moisture impermeable bag;
  • applying direct heat, such as a grill, heating coil, flame, or rotisserie;
  • cooking product in casings (most casings will prevent or inhibit moisture loss so that the heat resistance of pathogens is not affected during the cooking process); or
  • cooking beef patties by direct heat.

Therefore, if the establishment is citing Appendix A as supporting documentation for a process, it must meet the relative humidity requirements included in Appendix A (90% relative humidity for the entire process, 90% relative humidity for at least 50% of the cooking time, but in no case less than 1 hour), or if different than those included in Appendix A, validation of alternate humidity requirements must be provided.

Does policy require post-packaging process to be a CCP? If so why?(9-05)

If an establishment has identified a food safety hazard that is reasonably likely to occur in accordance with 9 CFR 417.2(a)(1) because of post lethality exposure, and has designed a post-packaging treatment to eliminate, or reduce the hazard to acceptable levels, then that post-packaging treatment must be incorporated in the HACCP plan as a CCP. This is required by 9 CFR 417.2(c)(2), which states that the HACCP plan must list the critical control points for each of the identified hazards.

FSIS has determined that contamination with L. monocytogenes (LM) is a hazard of concern in ready-to-eat products exposed to the processing environment post-lethality (Federal Register: 68 FR 34211, June 6, 2003) and has promulgated 9 CFR 430 in response to LM as a potential adulterant. FSIS allows establishments the latitude to include LM control measures in HACCP plans or to address potential contamination by this pathogen in Sanitation SOPs or other prerequisite programs. However, a post-lethality treatment cannot prevent contamination with LM, but can eliminate or reduce the organism to acceptable levels. Therefore, if an establishment is applying a post-lethality treatment to an RTE product, the establishment must have concluded that L. monocytogenes is a hazard reasonably likely to occur in the product. When this decision is made, the establishment must include that treatment as a CCP in its HACCP plan.

If you have a letter of guarantee and a program for verification, is there a requirement for yearly updating?(7-04)

If an establishment is basing decisions made in the hazard analysis on a prerequisite program, or a program for verification, it should be able to support that the supplier is continuing to meet the specifications or guarantees in the letter. Adequate documentation would provide information to the receiving establishment concerning the control of pathogens at the supplying establishment on an ongoing basis during the year, which likely would be more than once per year.

The "Compliance Guidelines for Establishments on the FSIS Microbiological Testing Program and other Verification Activities for Escherichia coli O157:H7" contains information regarding purchase specifications and letters of guarantee and may be found at the following link: www.fsis.gov/OPPDE/rdad/fsisdirectives/10010_1/ecoli157h7dirguid4-13-04.pdf