DRAFT 6/5/12. One Meating Place Elizabethtown, PA Phone: (717) Fax: (717) Website:

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1 DRAFT 6/5/12 One Meating Place Elizabethtown, PA Phone: (717) Fax: (717) Website: Docket Clerk U.S. Department of Agriculture (USDA) FSIS, OPPD, RIMD, Docket Unit Patriots Plaza Independence Avenue SW Mail Stop 3782, 8 163A Washington, DC Re: Comments - Docket No. FSIS HACCP Systems Validation June 5, 2012 The American Association of Meat Processors (AAMP) is pleased to and respectfully submits these comments regarding the reissuance of the Draft Guidance on HACCP System Validation that was publically released on May 9, AAMP applauds the efforts of the Food Safety and Inspection Service (FSIS) to develop a second, revised version FSIS Compliance Guideline HACCP Systems Validation April 2012 and its willingness to extend the initial comment period to allow another opportunity to comment on this very complex issue. AAMP sincerely appreciates that the Agency sought more extensive comments from stakeholders regarding the development of more applicable guidance for the meat industry. AAMP is an international organization whose members include meat and poultry processors, slaughterers, caterers, food service companies, wholesalers, retailers, suppliers, and consultants to the meat and poultry industry. There are 30 state, regional, and provincial associations of meat processors that are also affiliated with AAMP. The majority of our members are small and very small businesses, with most of them being them family-owned and operated. While the total group of small and very small meat processors in the U.S. represent about 5% of the total meat production volume in the U.S., those same type of meat processing businesses constitute approximately 95% of the total number of meat processing businesses in the U.S. As a national meat trade association, we are proud that we have members who own businesses of all sizes, but the backbone of our organization remains the small and very small independently owned firms across the United States. In what seems to be a continuously consolidating industry, the AAMP membership consists of a very unique group of very small and small independent meat processors that do not simply produce one meat product in a single establishment. Most all members produce a wide variety of fresh and processed meat products under numerous HACCP plans. This should come as no surprise to the Agency since its inspection personnel are conducting inspection activities in these establishments on a daily basis, but it seems as though this fact has had little impact on the Agency s decision to reinterpret the validation requirement which implies excessive, non-science based regulatory hurdles that will have negligible results in food safety and public health advancement. It has been nearly two years since the comment period was closed on the first draft of the validation compliance document. The meat industry has been anxiously awaiting resolution during that time with very little communication from any FSIS officials. Now that the second draft is finally available for public comment, it is a notable improvement and a positive step forward toward an applicable guidance document. It is apparent that FSIS did consider many of the comments made by the industry trade organizations, establishments, and the National Advisory Committee on Meat and Poultry Inspection

2 Page 2 AAMP Comments on Docket No. FSIS HACCP Systems Validation (NACMPI). It is our hope that the same level of attention to our comments and concerns is provided in this second round and until the document is finalized. Despite the best of intentions on creating an improved useful guidance document for validation, a fundamental question still remains. What legitimate food safety problem exists that validation will solve? The Agency justified the development of the validation document by stating the Agency enforcement actions have identified instances in which adequate validation has led to the production of adulterated product and in some cases even illnesses. Yet, industry trade organizations (including AAMP) requested that the since the first draft compliance document was released that the Agency publically provide data regarding these instances and the data has never been made available. No specific data has ever been provided so the meat industry can learn from these inadequacies and potentially improve food safety systems. The Agency seems to be assuming that all food safety systems are systemically failing and validation will resolve issues that have yet to be clearly identified to the meat industry. The following AAMP comments have been consolidated to focus on a limited number of main points regarding the issuance of any guidelines regarding HACCP system validation. Validation Concept Food safety has been a top priority for the meat industry as a whole and the AAMP membership, not only since the implementation of HACCP, but long before the HACCP regulations were implemented. The AAMP membership s family-operated businesses continue to produce safe, high quality meat products for consumers on a daily basis. It is also important to recognize that AAMP members are not only producing these meat products for the general public, but also for their own families. Many AAMP member establishments have been operating under HACCP since its initiation in 2000, and others have been operating under HACCP food safety systems for a number of years. To that point, they had to already validate their food safety systems. This activity was conducted and already approved by the Agency to enable establishments to produce meat products to this day. Failure to take steps to validate would raise questions, but a direct relationship between validation to an establishment s food safety system or ineffectiveness of producing a safe and wholesome product has not been proven. If these establishments do not have validation records after years of operation, it is now automatically assumed that their food safety systems are inadequate even though there is no proof. These same establishments have reassessed their HACCP food safety systems annually to address emerging food safety related concerns as well. It is also likely that they have all been through extensive Food Safety Assessments (FSA) conducted by the Agency s Enforcement, Investigation, and Analysis Officers (EIAO). In essence, USDA/FSIS is telling establishments and the public that after a decade of operating under HACCP regulations, the meat industry has not proven that their HACCP plan is being executed properly. This is completely false and unjustified. Food safety issues may arise periodically, but this does not mean that all food safety systems are a systematic failure. Through the years, HACCP plans and food safety systems have been designed, redesigned, and/or reassessed at each federally inspected establishment annually as now required under 9 CFR and under the recently amended Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) by section of the Food, Conservation, and Energy Act of 2008, Public Law , 122 Stat 1651, , otherwise known as the 2008 Farm Bill. The HACCP food safety systems have also been addressed on an even more frequent than annual basis, when it is needed. These reassessments help processors focus on any emerging food safety related concerns. Processors have taken many steps to keep their food safety plans current and have addressed issues such as: potential E. coli O157:H7 contamination on beef carcasses and the production of ground beef, potential Listeria monocytogenes contamination in ready-to-eat (RTE) meat products, Bovine Spongiform Encephalopathy (BSE) concerns in older beef animals, and the thermal processing of jerky items. These are just a few examples of focused reassessments that lead to the production of safer meat products.

3 Page 3 AAMP Comments on Docket No. FSIS HACCP Systems Validation The USDA/FSIS is interpreting validation in a completely different fashion compared to what has been accepted since its creation in The industry has been following the initial intent of validation since the HACCP regulations were initiated. The establishments developed the HACCP plans and food safety systems. After the plans were established, they were critically evaluated to determine that the plans were functioning as they were intended. Critical limits were established using supporting documents and monitoring activities were conducted. Now, according to the Agency, establishments have not adequately identified critical operating parameters. If they have not done this yet, then what gives establishments the ability to currently achieve Agency expectations and produce safe meat and poultry products? Establishments have made improvements to their food safety system, with the assistance of the Agency in some instances, by refining their supporting documentation, monitoring activities, or processes. No specific data has been provided to the industry of instances of inadequate validation resulting in the production of adulterated or otherwise unwholesome meat and poultry products, so it is assumed that there no systematic problem. Page 19 of the guidance document reads: The purpose of validation is to demonstrate that the HACCP system as designed can adequately control identified hazards to produce a safe, unadulterated product while the purpose of ongoing verification is to support that the HACCP system is functioning as intended on an ongoing basis. How is USDA/FSIS going to measure the impact of this process? Can repeating initial validation even accomplish its purpose? In the end, a majority of processors will learn absolutely nothing from this guidance document and the Agency s validation expectations. This guidance document lacks focus as there has been no goal identified to achieve. Establishments may not change their processes and food safety will not be impacted or improved to surpass current practices. The Agency is proposing to create an impractical level of standards that is unlikely to produce safer food, and may harm the consumer by potentially discouraging meat establishments from implementing new or existing food safety strategies or interventions due to the cost of validation, eliminating current food safety strategies due to the expected validation obligations, and may ultimately increase food prices for food produced by fewer companies. The Reinterpretation of the Preexisting Validation Requirements Since the implementation of HACCP, the meat industry has utilized the Agency endorsed practice of justifying critical food safety points with supporting documentation (e.g., published processing guidelines, scientific articles from peer-reviewed journals, a challenge or inoculated pack study, data gathered inhouse, or regulatory performance standards, etc.). The interpretation of validation is already in writing and has been in writing since 1996 in 9 CFR 417.4(a)(1) Validation, Verification, Reassessment which states: Upon completion of the hazard analysis and development of the HACCP plan, the establishment shall conduct activities designed to determine that the HACCP plan is functioning as intended. During this HACCP plan validation period, the establishment shall repeatedly test the adequacy of the CCP s, critical limits, monitoring and recordkeeping procedures, and corrective actions set forth in the HACCP plan. After nearly 16 years of HACCP, the Agency is suggesting that establishments go back to the beginning and redo initial validation. Since the meat industry and the Agency have been following the same interpretation of validation since it was written in 1996, it is completely inappropriate for the Agency to make such a significant reinterpretation and drastic change to their long-standing policy regarding validation. This potential reinterpretation is degrading the platform of the current HACCP food safety system and gives the impression to the meat industry and the public that the current food safety system is so badly broken that everyone needs to start over from the beginning. It is AAMP s opinion that the

4 Page 4 AAMP Comments on Docket No. FSIS HACCP Systems Validation current food safety system is not broken, but may be flawed. The Agency should acknowledge and except the usage of such well-known and implemented supporting documentation. The documentation coupled with sufficient monitoring procedures should be enough to satisfy the validation criteria. All of this information is available to Agency personnel to verify that validation criteria have been met. The Demonstration That a Food Safety Problem Exists AAMP is struggling to determine the existence of a clear food safety problem which this validation initiative will resolve. In fact, during the NACMPI public meeting on September 22, 2011, FSIS officials were pressed by that question and they could not give a definitive answer or explanation. AAMP is troubled that FSIS believes so strongly that the current HACCP system is so badly broken to such an extent that this type of focus on validation must occur, especially given the fact that the very small plants started HACCP in January, 2000, and the small plants started HACCP in January, The meat industry has been under HACCP for 10 years (if not longer) and this initiative pushes the industry back to the beginning without any clear and present need. The Agency identified a very limited number of indirect examples in which it claims that the meat industry s inadequacy to address validation has resulted in recalls. It is unknown if these inadequacies were related to public illnesses or recalls, since details of each and every example are unknown to the industry. AAMP questions whether the contamination was truly due to an inadequately validated critical control point (CCP) or an establishment s failure to properly execute the CCP that was identified in the HACCP plan, or due to post-ccp contamination that may have occurred. The Agency has portrayed the limited, speculative examples given as overall meat industry systemic problems, and AAMP has doubt whether this is truly the case. Years ago, the Agency identified a potential food safety issues that could occur with jerky products if they were not properly thermally processed with humidity being addressed. After observing the issues that caused the concern, it was determined that a problem was identified with only three processors, two of which were not officially confirmed. The point being, if the Agency identifies an issue in a limited number of establishments, it does not necessarily mean that a universal problem exists. FSIS has the responsibility to assure that meat products produced in the U.S. and imported into the U.S. are safe and wholesome. Agency inspection personnel can review records contained in an establishment s HACCP, SSOP or prerequisite programs to make a determination that the food is wholesome, not adulterated and properly labeled. FSIS has the responsibility to verify the adequacy of the HACCP plan, not the entire food safety system. The HACCP regulations describe those activities as primarily records review, observations and sample collection. The idea that the Agency can require endless sampling and validation activities is simply not supported by the HACCP regulations. The criteria for applying the marks of inspection are described in the meat and poultry laws, not in the interpretation of those laws by an endless number of Agency employees. The Agency should acknowledge and accept an establishment s implementation of peer-reviewed documents, regulations, and regulatory guidance as being adequate to address validation. AAMP does understand and recognize that if such documentation is utilized to justify prerequisite programs and CCPs then they should be understood, utilized, and implemented properly to ensure the production of safe meat products. Overall, as AAMP reviewed both the first and second draft validation documents, it became obvious that the Agency tended to be concerned with a few points: E. coli O157:H7 contamination during beef slaughter, presence of E. coli O157:H7 in the production of ground beef and non-intact products, and Listeria monocytogenes contamination of ready-to-eat meat products. If this is the case, the Agency should refocus its efforts to provide specific and clear guidance on those issues.

5 Page 5 AAMP Comments on Docket No. FSIS HACCP Systems Validation Initial Validation vs. Ongoing Verification AAMP appreciates the chart illustration that attempts to show some of the key differences between initial validation and ongoing verification and shows the sequence of these key steps, but would like to offer some comments. First, in describing initial validation, the purpose is stated as, To get experience with the HACCP system. Is ten years of HACCP not enough experience for establishments? Under the process heading, the process is explained as repeatedly testing all critical operating parameters to show that establishments are effective at controlling the identified hazards. AAMP questions this statement because it is not clear if an establishment will be controlling the identified hazards, or more likely implementing and monitoring the critical operating parameters of the scientific supporting documentation. The example given is ineffective and shows the impracticality of this process and the lack of understanding of small meat processors, which this guidance document was intended to aid. The equipment listed is a CHAD cabinet. That type of equipment and technology is generally not utilized by much of the very small and small meat industry. Furthermore, the ongoing verification activities that are listed are completely unreasonable. Is the agency is really expecting a small or very small establishment to monitor and verify all of the parameters on a continuous basis? That is unacceptable to AAMP. These businesses will have to hire more employees to simply document their processes, which is not financially feasible. The Use of Scientific Supporting Documentation For years, the meat industry has utilized scientific supporting documentation to support decisions made within HACCP food safety systems. The Agency should acknowledge that such documentation does not exist for every action conducted in establishments, and therefore decision making documents are not available for every process. After more than a decade of functioning under the HACCP regulations, the Agency should have knowledge whether an establishment has the overall proper scientific supporting documentation (e.g., scientific supporting documentation vs. supplier specification information). This is especially true considering the fact that inspection personnel are in establishments on a daily basis and extensive EIAO FSAs are conducted. AAMP is concerned that, with this reinterpretation of the validation requirements, more unneeded scrutiny will be placed on the supporting documents that establishments have utilized for years that have not resulted in the occurrence of food safety issues. This concern is the result of statements made within the draft guidance such as care should be taken to ensure that the supporting validation documentation is sufficiently related to the process and the process should also be implemented in the establishment as described in the supporting documentation. This is a completely subjective statement that can easily be argued. Another statement made within the guidance document refers to the fact that in order for an establishment to provide adequate validation, the study needs to relate closely to the process with regards to species, product, characteristics, and equipment. Will the establishments or FSIS be making that determination? Unfortunately, since there is no stringent detail to define closely, the FSIS field interpretation may cause enormous controversy, debate, and problems for the meat industry. All of these statements are very concerning because supporting documents very rarely relate closely to the process with regards to species, product, characteristics, and equipment. A perfect example is the use of FSIS Appendix A (Compliance Guidelines for Meeting Lethality Performance Standards For Certain Meat and Poultry Products) and Appendix B (Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization)). The specific research that was performed to develop the contents of Appendix A is somewhat unknown to most within the meat industry. Furthermore, initial statements made within Appendix A allude to the fact that it was developed for establishments that produce ready-to-eat roast beef, cooked beef and corned beef products and certain ready-to-eat poultry products. Moreover, it only addresses control of Salmonella and not the other common pathogens of concern that are identified in current food safety systems. Therefore, when statements are made that documentation must relate closely to the process with regards to species, product, characteristics, and equipment, AAMP is concerned that many commonly used supporting documents will not be acceptable

6 Page 6 AAMP Comments on Docket No. FSIS HACCP Systems Validation in the eyes of Agency inspection personnel because they may not be related closely enough to the establishment s process, species, product, characteristics, and/or equipment. AAMP believes there may be many other examples where parameters identified in scientific supporting documents may not be critical to the effectiveness of the intervention. While credible Universities conduct research, many factors may be measured throughout each project. Some factors may be measured because they are critical to the effectiveness of the intervention and other factors may be measured and collected simply because it is basic data that may be needed to pass the scrutiny of the peer review process. Unfortunately, the data collected or parameters measured are not identified as critical and noncritical. Also, it may be difficult for the establishments to determine this distinction and provide Agency inspection personnel with this evidence. Therefore, the establishments will be forced to measure all parameters. AAMP has concerns with the information provided in this second draft compliance guidance document regarding supporting documentation. A key definition is given for scientific support in the document stating, Scientific support is the theoretical principles, expert advice from processing authorities AAMP would like FSIS to please define a processing authority more clearly. Within 9 CFR 301.2, it provides a vague definition of a person or organization with expert knowledge in meat production process control and relevant regulations. AAMP believes that many meat establishment owners fit this vague definition very well, but unfortunately their opinion on food safety matters are typically not determined to be credible enough when faced with Agency scrutiny regarding food safety issues. From historical experience, the Agency would rather rely on a paid, third-party individual who may or may not have experience with the issue at hand, and in many instances has never even been at the meat establishment. This all seems counter-productive to improving food safety of meat products. On page 8, the guidance document provides a list of what the scientific supporting documentation should identify. The expected level of hazard reduction or prevention to be achieved is noted as a point to be identified. Many documents do not provide this information (e.g., temperature control documents for raw meat products, FSRE documentation on shelf stability, etc.). Some commonly used scientific supporting documentation simply provides only a critical limit. For example, many processors utilize documentation that may only provide a temperature that permits growth of specific pathogens when producing raw meat products. This documentation does not contain microbiological data associated with the critical limit provided. In another example, processors may use critical parameters identified in the scientific supporting document Microorganisms in Foods 5 to establish critical limits for shelf stable meat products. Again, this documentation does not contain specific microbiological data associated with the critical limits provided. How does the Agency plan to address this issue when such stringent guidance is provided to both the meat industry and inspection personnel? Temperature control documents along with much of the FSIS guidelines (e.g., jerky guidelines) do not contain microbiological data specifying the level of pathogen reduction achieved by the intervention strategy. In another example, the use of FSIS Appendix A, which is a very common document used to justify the critical control point of thermal processing. Within that document, most individuals would recognize the critical parameters are temperature (or temperature/time relationship), relative humidity, and dwell time. The 7-log pathogen reduction of Appendix A is an estimate while the guidelines in Appendix B are only based on models. In other scientific supporting documentation, research may measure a variety of factors throughout the research project. Most likely, not all factors identified within the scientific supporting document are critical to the effectiveness of the intervention. Also noted as a point to be identified is, the processing steps that will achieve the specified reduction or prevention, and how these processing steps can be monitored. AAMP questions what FSIS means by this and asks for an example of a scientific support document that details this information. The guidance document notes that, Implementing an intervention based on supporting documentation that didn t contain data supporting the processes effectiveness. For example, having a hazard analysis that cited E. coli O157:H7 as a hazard reasonably likely to occur but the supporting documentation contained microbiological data for Salmonella. This statement is in direct conflict with the use of Appendix A. FSIS Appendix A clearly

7 Page 7 AAMP Comments on Docket No. FSIS HACCP Systems Validation outlines the products that the guideline was intended for (i.e., cooked beef and roast beef, including sectioned and formed roasts, chunked and formed roasts, cooked corned beef, cooked poultry rolls, and other cooked poultry products) and delineates the lethality performance standards for the reduction of Salmonella. The validation guidance clearly reveals that the scientific documents sufficiently relate to the process, product, and hazard identified in the hazard analysis. Yet, it has been a long standing Agency policy to allow the use of FSIS Appendix A to support the proper lethality of all pathogens and was allowed to be utilized for the production of all for all ready-to-eat meat products. Therefore, based on the validation guidance provided, inspection personnel could potentially declare that it is no longer valid to use FSIS Appendix A because it doesn t sufficiently relate to the process, product, and hazard identified in the hazard analysis. AAMP doesn t have access to this long standing Agency policy, but believes the Agency should address this issue now within the validation guidance before it gets potentially misinterpreted by the meat industry and/or the inspection personnel tasked with confirming that validation was completed correctly. Also, in the same section of the guidance document, a Key Question is answered about using a different level of a critical operating parameter than what is used in a scientific support document. FSIS answers, In these cases, establishments should provide justification supporting that the levels chosen are at least as effective as those in the support documents. This justification is needed because higher levels of a critical operational parameter may not always be equally effective. For example, antimicrobial agents may only be effective within a range of concentration after which point efficacy may decrease. Where is FSIS s justification for supporting such a statement that higher levels of critical operational parameter are not equally effective? If a support document dictates that a product should be held at 41 F and a processor holds the product at 35 F does the establishment have to provide justification supporting such a common sense decision? The critical limit is established to address the food safety hazard of concern, but in some instances, the processors may choose to exceed the critical limit to improve the quality of the final meat product. For example, thermal processing snack sticks to a higher internal temperature than stated in the USDA/FSIS Appendix A document. Another example may be the production of jerky products. Commonly, shelf-stable jerky has a water activity of 0.85 or less, but some processors may reduce the water activity lower than 0.85 for quality issues or an extended shelf life. Has FSIS now created an issue where processors will have to provide supporting documentation for all of these decisions? If so, the Agency should understand that such supporting documentation may not exist. Pathogen in the Plant Environment and the Use of Indicator Organisms The guidance document is clear in noting that FSIS does not advocate the introduction of pathogens in the plant environment. AAMP questions how does one then relate the effectiveness of the food safety strategy to a specific pathogen and adhere to the process that actually occurs in the plant? In September of 2002, FSIS released a guidance document titled, Guidance for Minimizing the Risk of Escherichia coli O157H:7 and Salmonella in Beef Slaughter Operations. It states that indicator organisms are especially useful for validating process implementation and verifying process control. Pathogen testing is not useful for verification purposes because pathogens usually occur at low levels and are distributed non-randomly. Unfortunately, the same document states that there are many difficulties when utilizing indicator organisms to prove pathogen control. One issue is the impact of non-homogeneous distribution of both indicator organisms and pathogenic organisms in meat and poultry. Indicator organisms may be concentrated in one part of the carcass or the meat, which is not necessarily the same location where the pathogens are concentrated. Another consideration is whether the effects of control, decontamination or intervention methods on indicator organisms are similar to the effects on the pathogens. Organisms may react differently or have different survival rates as a result of the application of organic acid sprays depending on their acid tolerance. Tests for indicator organisms may be used successfully when there is sufficient data collected to establish or indicate a relationship between the occurrence or level of a pathogen or toxin and the indicator organism (AMSA, 1999). Data can be collected from studies using indicator organisms which parallel the

8 Page 8 AAMP Comments on Docket No. FSIS HACCP Systems Validation data in a challenge study performed with inoculated pathogen in another or the same study. If a similar and consistent reduction or control can be established, then control of the indicator organism can be reliably used to indicate expected pathogen control in commercial application. Tests for indicator organisms may be used successfully when there is sufficient data collected to establish or indicate a relationship between the occurrence or level of a pathogen or toxin and the indicator organism. Unfortunately, studies on the effects of interventions on pathogen control methods on indicator organisms are commonly done separately, so that correlation of the effect on the pathogens and indicator organisms cannot be established. Just because a scientific supporting document may contain data for both indicator organisms and pathogens, typically the effects of the intervention on pathogens and on indicator organisms are done separately. Therefore, a direct scientific correlation between the pathogen and the indicator organisms is never established. Essentially meaning that a reduction of an indicator organisms does not prove and equal or mathematically calculable reduction in the pathogen of concern. The document leaves the window open stating however, if establishments can demonstrate that there is an organism that can be used as an indicator organism for a pathogen of concern; this organism could be used for validation of CCPs. Many very small and small processors will not have the resources to conduct such rigorous and costly challenge studies. This information from USDA/FSIS proves that correlation documentation, if it exists, would most likely not satisfy the validation scientific support document requirements. Also, the use of indicator organisms to validate CCPs is a very difficult process that most small and very small meat processors would not have the technology or resources to perform. AAMP is also concerned about the use of challenge studies as sufficient validation for HACCP systems in light of the recent release of FSIS Notice This notice, FSIS Verification of Lebanon Bologna Processes, gives the meat industry the impression that the challenge study performed for this product would not meet validation expectations because the study does not relate closely enough to the actual process. The Notice claims, An FSIS investigation into the processing of the product revealed that the establishment relied on supporting documentation, a published study, which did not match the actual commercial process used. In the support, to represent a commercial process for Lebanon bologna, raw Lebanon bologna mix was compacted in 27 millimeter diameter impermeable sealed glass tubes that were immersed in a well-controlled water bath. However, in the actual process at the establishment, raw Lebanon bologna mix was compacted in 52 to 119 mm diameter permeable casings that were placed in a large smokehouse fitted with a single source of heat and humidity that was not well-controlled. For these reasons, it is important that the support used by the establishment is representative of the establishment s actual process, so that the results can be repeatable. If a challenge study is performed in a theoretical laboratory setting instead of the actual plant environment will FSIS now consider the process invalid? These challenges studies are extremely expensive and if they are not conducted in the establishment is can be easily assumed that FSIS may utilize this validation guidance document to justify the subjective decision that the challenge study has not sufficiently related to the process, product, and hazard identified in the hazard analysis. It is nearly impossible to ensure that a challenge study conducted in a laboratory will meet Agency expectations that it relate and adhere to the critical operational parameters of the processing environment in the establishment. Identification of Critical Parameters Page 15 of the guidance document gives establishments examples of several questions one can ask to help identify the critical operating parameters in scientific support documents. These questions are very specific for establishments to ask when attempting to interpret scientific literature in order to identify critical operating parameters. Processors may not have this knowledge base or expertise to evaluate these documents and determine all of the critical parameters. Moreover, much of FSIS inspection staff may not have those skills either. The section provides limited guidance for determining critical parameters.

9 Page 9 AAMP Comments on Docket No. FSIS HACCP Systems Validation Once again, FSIS believes that meat processors are researchers and microbiologists. There is an obvious disconnect between FSIS and the industry they regulate, particularly the small and very small establishments. AAMP fully supports the NACMPI recommendation to create a third party consortium to perform this function, which was blatantly ignored by FSIS when developing this second draft guidance document. Appendix 1: Guidance to Identify Critical Operational Parameters from Supporting Documentation attempts to help establishments understand how to read scientific literature and identify the critical operational parameters used in a study. Although FSIS stresses the importance of identifying critical operational parameters, once again there is a failure to recognize that the industry may not have this skill set, nor the time or resources to devote to this process. AAMP offers that it would be a helpful addition to Appendix 1 to include a sample analysis of Appendix A and Appendix B since these Agency documents and are commonly utilized as scientific support. The Agency should be able to easily analyze their two documents and identify the critical parameters. AAMP finds this section of the guidance document difficult to understand and does not expect the industry to easily understand it and be able to affectively apply it to the validation process. This is also true with inspection personnel and EIAOs. If issues are left up to the subjective nature of inspection personnel; frustration and confusion will most likely occur. However, from historical experience with the EIAO FSA process, when inspection personnel do not understand scientific literature, they oftentimes will push it on to someone that does (or is believed to understand). Many processors may not have access that type of network. AAMP does not find it acceptable for FSIS to simply throw these expectations of assisting meat processors with scientific support documents upon academia and extension educators. Within a response to a question in the Federal Register Notice Docket No. FSIS HACCP Systems Validation, the Agency stated that, The Agency is also developing a tutorial on understanding scientific and technical journal articles and identifying critical operational parameters. FSIS will post that material on the Web site when it is complete. AAMP hopes that this tutorial will in fact be completed and be available when the validation guidance document is finalized that it will be more helpful than the guidance document itself in aiding processors to understand technical journal articles and identifying critical operational parameters. Why must a supplementary document be developed when this guidance document should provide that important information? Matching Scientific Support AAMP believes the Agency should work with the meat industry in regards to providing some latitude because scientific supporting documentation does not exist for every process, species, product, characteristic, and/or equipment. Nor can the meat industry afford to provide individualized research on every process, species, product, characteristic, and/or equipment at each establishment. The guidance document is not specific enough in explaining how closely supporting documentation must match an establishment s process, species, or products. There are obvious boundaries when choosing matching supporting documentation that AAMP recognizes. The Agency has frequently cited the extreme example of the usage of a scientific support document related to controlling pathogens in apple cider as supporting documentation for a meat product. While those types of instances are regularly monitored and corrected during FSAs, AAMP once again cautions the Agency on the potential for confusion and disagreement between processors and inspection personnel when scrutinizing the closeness of matching papers to actual product and plant operations. The inspection personnel should be directed not to overextend the use of the validation regulation simply because the supporting document does not match the establishment s production precisely.

10 Page 10 AAMP Comments on Docket No. FSIS HACCP Systems Validation NACMPI Recommendations On September 22-23, 2011, the NACMPI held a public meeting in Washington, D.C., where validation was discussed by the sub-committee. Ironically, the meeting date occurred exactly two years after a hand-delivered letter was given to Mr. Al Almanza, Administrator FSIS, regarding the issue. The major role of the Committee is to advise the Secretary of Agriculture on food safety policies that will contribute to USDA's regulatory policy development. While several NACMPI recommendations were taken into consideration to further clarify the guidance document, the following recommendations were developed by the committee that FSIS did not address nor take into advisement when revising FSIS Compliance Guideline HACCP Systems Validation - April 2012: The committee recognizes the unique needs of small and very small establishments, and recommends that additional resources be developed to assist them in meeting validation requirements. Development of these resources should be prioritized based on public health risk. In accordance with FSIS Strategic Plan, Goals 4 and 7, the Subcommittee submits the following recommendations: FSIS should identify and broadly share the top priorities (categories, processes, etc.) in which there are validation problems that resulted in documented and confirmed food safety issues; To the extent that FSIS has not done so, the Agency should adopt a phase-in, risk-based approach of the new validation guidelines in normal HACCP re-assessments; FSIS should encourage and support the creation of a consortium of scientists, processors, academics/extension specialists, consumer organizations, trade organizations, regulatory / government officials, and NGOs to focus on validation principles; The principles identified in the guidance are a good starting point but would be strengthened by providing additional specific examples of strategies for efficiently and safely grouping product categories for the purpose of validation. Keeping the needs of small and very small processors in mind, the goal should be to provide sufficient practical examples to illustrate how: 1. Typical products can be grouped into a workable number of product categories, and 2. Worst case products within a grouping can be selected for validation purposes. In the case of atypical products and/or extenuating circumstances, FSIS HQ would need to provide additional validation guidance on a case-by-case basis. AAMP fully supports all the recommendations, mainly the call for a consortium to review scientific literature and identify critical operating parameters, made by the Committee and questions their absence and of consideration in the second draft guidance document and the Federal Register Notice. The Benefit of Collecting Validation Microbial Data A Key Question is posed in the guidance document: Is microbial data required to comply with the initial validation requirements? The answer is no. Microbiological data is encouraged but not required. AAMP recognizes this as a typical, forceful way for the Agency to achieve its goal by encouraging its expectations. The guidance document provides steps for an establishment to perform when the scientific supporting documentation used does not contain microbiological data specifying the level of pathogen reduction achieved by the intervention strategy for the target pathogen identified in the hazard analysis. The steps included validating that the intervention as modified actually achieves the effect documented in the scientific supporting documentation, validating that the modified critical operating parameters are

11 Page 11 AAMP Comments on Docket No. FSIS HACCP Systems Validation being met, and validating the intervention s effectiveness under actual in-plant conditions. These steps are written to mask the true intent of FSIS requiring microbial testing. It is important to understand that with the lack of any scientific, peer-reviewed supporting documents regarding validation and lack of defense why microbial sampling validation is not needed, the Agency will potentially use 9 CFR 417.5(a)(2) against the meat industry and use this guideline as a minimum expectation of validation. This includes the microbial sampling issue. Currently, it is well understood by the meat industry that produces raw ground beef products that E. coli O157:H7 testing is not required, but in many instances the meat industry also knows that testing for E. coli O157:H7 is the only way to satisfy Agency expectations. So, although in some instances microbiological testing is not required, it is inadvertently mandated on the meat industry with the command-and-control attitude of yesteryear. It is AAMP s expectation that this current reinterpretation of the validation expectations will not result in the manipulation of current HACCP regulations in which excessive, unscientifically-based microbiological testing will be the component that satisfies the Agency expectation of proper validation information that is provided by establishments. AAMP believes the Agency should reevaluate the benefit of performing microbial sampling if the initial sample and the final sample are both negative for the pathogen of concern. At that point, the Agency and the establishments have achieved absolutely nothing. This is not validation, but rather it is simply microbial sampling for the sake of satisfying an Agency expectation. Unfortunately, in the end, very little benefit is achieved. The intent of the implementation of the new HACCP system in 1996 was based on the prevention of harmful foodborne pathogens from entering commerce because end product testing was not solving the food safety related issues. Unfortunately, the Agency is continually reverting to excessive end product microbial testing of meat products to control potential pathogens instead of relying on an establishment s HACCP food safety systems. The fact of the matter still stands: The Agency and the meat industry cannot test its way to the production of safer meat products. Validation Authority and Implementation Although the Agency continually reinforces that the validation information is guidance and not regulation, it seems as though the Agency has taken a very naïve approach of how these guidance documents are interpreted at the establishment level by its own inspection personnel. Over the years, the meat industry has learned that guidelines quickly become minimal Agency expectations; and in the absence of any other supporting documents available to present to FSIS (which in some cases, none exist), microbial sampling data may be the only data that will satisfy those expectations. The U.S. meat inspection system is very robust; and although specific regulations exist, many times the inspection that is implemented is based on expectations and interpretations of those written regulations. The Agency is very effective at manipulating the written HACCP regulations to encourage the use of Agency guidelines; because they understand that in some instances no further supporting documentation exists. The validation draft guidance gives Agency inspection personnel open-ended authority to harass establishments with frivolous non-compliance reports citing 9 CFR (Validation, Verification, Reassessment). Years ago, the information provided to the Agency inspection personnel in regards to validation was obviously accepted by the Agency after the first 90 days of HACCP plan implementation. In regards to the validation issue, the Agency shouldn t make statements that this shift in validation policy is due to the fact that HACCP is evolving or is a living document. The HACCP regulation has been in place for over a decade, and the Agency is now stating that the meat industry needs to go back to the beginning steps of HACCP development and provide initial validation information. By telling the industry that what they did a decade ago was acceptable, but now suggesting change in validation policy, it

12 Page 12 AAMP Comments on Docket No. FSIS HACCP Systems Validation unfortunately creates mistrust and an adversarial relationship when, the main goal for both the meat industry and the Agency is food safety. The Association and its membership would like some assurance that the validation information that is given today will be accepted in the future and not challenged by rotating inspection personnel or EIAOs each time an FSA is conducted at establishments. Simply put, the meat industry trusted that they previously satisfied the validation years ago only to be currently challenged because the Agency decided to reinterpret the regulation, clarify the existing regulation, or change its policy. AAMP would like to know, as this process continues, what Agency personnel are going to be tasked with reviewing all of the provided validation information and making the determination that the validation information provided is adequate. Is the Agency going to rely on its inspection personnel that conduct daily inspections at each establishment, the EIAOs, or some other inspection personnel within FSIS to make the final determination that the Agency s validation expectation has been satisfied? Moreover, if FSIS is going to rely on EIAOs to audit the efficacy of the validation information provided, AAMP would like to know how the Agency expects to expedite this process. AAMP would also like to know who is going to provide each establishment with the final approval that validation has been met, and would this be documented in a fashion so that establishments are not continually challenged regarding the information provided? After reviewing the second draft compliance document, AAMP is unsure how the Agency is making statements that establishments must validate at least one product per HACCP category. The language in the document does allow establishments to group products and provides limited examples, which is an improvement from the original guidance document. AAMP questions whether this will be truly acceptable to inspection personnel and won t be scrutinized when the validation information is provided. This concept seems like it may cause confusion when considering that different species are slaughtered and processed under similar and/or different HACCP plans. There are also a wide variety of products produced under the fully cooked, not shelf stable HACCP plan category. Although the products are produced under one HACCP plan, they have variable formulations, production processes, and thermal processing schedules. It may be extremely difficult, if not impossible, for meat establishments to justify or provide supporting documentation for how they grouped products or why they provide validation information for certain products and not for others. It is also an interesting point that the Agency, once again, encourages establishment to have additional validation data for more than one product within a HACCP category. AAMP would like to know who has the final decision in determining if enough products were initially validated again. There is more guidance provided in this revision, but it seems that this may be an issue of continual debate. The document reads that establishments should use decision-making documents and food science principals in making the determination on products. AAMP would like the Agency to provide these decision-making documents, and please define food science principals because meat processors are not food scientists. In most instances no credible reason will be available to justify these decisions. The Agency seems to be instructing the meat industry to conduct its own individualized risk assessment of the products produced and make the appropriate determination without any guidance from the Agency. Therefore, if the establishment is challenged on its decision, it will be put into a situation of conducting initial validation whenever inspection personnel deem necessary. The guidance document addresses the concerns about validation record keeping and offers specific guidance to small and very small plants explaining, FSIS recognizes that many small and very small establishments do not operate daily. Therefore, a minimum level of records from 13 production days within those initial 90 calendar days should be used to initially validate a small or very small establishment s HACCP system. AAMP questions this statement. What if products are not made in every HACCP plan category and they cannot obtain 13 production days? For example, an establishment might slaughter pigs every 2 weeks and slaughter beef every 2 weeks. In 90 days that is only 12 weeks. Therefore, the establishment would only have 6 production days. If an establishment has not manipulated its production schedule, how would the Agency address such issues? This will most likely be an issue for the small and very small establishments which is a majority of the inspected industry.