United States Food Safety Washington, D.C Department of and Inspection 20250 Agriculture Service September 8, 1999 TO THE USERS OF THESE VOLUMES As some of you may know, the Food Safety and Inspection Service(FSIS)received a substantial package of comments on its Guidebook for Hazard Analysis and Critical Control Point(HACCP) Plan Development and the 13 Generic HACCP models, from a coalition of industry and trade associations. This package represents a large and thoughtful effort on the part of these organizations. FSIS intends to give it the careful attention and response that it deserves The comments included many technical suggestions for improvements in the FSIS documents. It also included reiteration of longstanding differing policy viewpoints that have been frequently discussed by the agency and the regulated industry For the first time, the comments revealed substantially differing expectations on the part of these organizations and FSIS with respect to the purpose of the FSiS documents and their intended use. We want to address some aspects of this latter point When the Pathogen Reduction/Hazard Analysis and Critical Control Point systems(PA/HACCP) final regulation was published on July 25, 1996, the DRAFT Guidebook was included as an appendix. The Generic Models, developed for FSIS under contract, were available shortly thereafter in April 1997. It was probably inevitable that there were significant differences between the final regulatory language of CFR Part 417 and the dRaFT Generic Models as they were developed independently. It would have been inappropriate for FSIS to discuss its final regulatory language with any outside group The contractor was appropriately proceeding from what it knew best, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) documents on the subject of HACCP. Therefore, FSIS accepted that work product with full knowledge that significant revisions would be necessary As time passed, FSIS managers became increasingly uncomfortable with the situation in which its major technical assistance documents did not appropriately and completely inform the regulated industry of Agency expectations regarding regulatory compliance. Because the intended audience for these technical assistance materials was primarily the very small began the systematic re vision of the documents to overcome this problem. We targeted the z stablishment, which the Agency believed to have the least HACCP-experience, the agency summer of 1999 as the completion date for this effort FSIS now believes that others had very different ideas about the purpose and use of the documents than it did. As is consistently reiterated in the documents themselves, they are not designed to be used"as is. "That is, they cannot be copied and used by an establishment to meet all the regulatory requirements of 9 CFR Part 417. Nor were they designed to be the ultimate teaching and training materials, as some would suggest. The development of ideal generic models is left to others who may have an interest in doing so. The generic models are not FSIS Form26309(6/86 EQUAL OPPORTUNITY IN EMPLOY MENT AND SERVICESUnited States Food Safety Washington, D.C. Department of and Inspection 20250 Agriculture Service September 8, 1999 TO THE USERS OF THESE VOLUMES As some of you may know, the Food Safety and Inspection Service (FSIS) received a substantial package of comments on its Guidebook for Hazard Analysis and Critical Control Point (HACCP) Plan Development and the 13 Generic HACCP models, from a coalition of industry and trade associations. This package represents a large and thoughtful effort on the part of these organizations. FSIS intends to give it the careful attention and response that it deserves. The comments included many technical suggestions for improvements in the FSIS documents. It also included reiteration of longstanding differing policy viewpoints that have been frequently discussed by the Agency and the regulated industry. For the first time, the comments revealed substantially differing expectations on the part of these organizations and FSIS with respect to the purpose of the FSIS documents and their intended use. We want to address some aspects of this latter point. When the Pathogen Reduction/Hazard Analysis and Critical Control Point systems (PA/HACCP) final regulation was published on July 25, 1996, the DRAFT Guidebook was included as an appendix. The Generic Models, developed for FSIS under contract, were available shortly thereafter in April 1997. It was probably inevitable that there were significant differences between the final regulatory language of CFR Part 417 and the DRAFT Generic Models as they were developed independently. It would have been inappropriate for FSIS to discuss its final regulatory language with any outside group. The contractor was appropriately proceeding from what it knew best, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) documents on the subject of HACCP. Therefore, FSIS accepted that work product with full knowledge that significant revisions would be necessary. As time passed, FSIS managers became increasingly uncomfortable with the situation in which its major technical assistance documents did not appropriately and completely inform the regulated industry of Agency expectations regarding regulatory compliance. Because the intended audience for these technical assistance materials was primarily the very small establishments, which the Agency believed to have the least HACCP-experience, the Agency began the systematic revision of the documents to overcome this problem. We targeted the summer of 1999 as the completion date for this effort. FSIS now believes that others had very different ideas about the purpose and use of the documents than it did. As is consistently reiterated in the documents themselves, they are not designed to be used "as is." That is, they cannot be copied and used by an establishment to meet all the regulatory requirements of 9 CFR Part 417. Nor were they designed to be the ultimate teaching and training materials, as some would suggest. The development of ideal generic models is left to others who may have an interest in doing so. The generic models are not FSIS Form 2630-9 (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES