UsDa Guidebook for the United states Preparation of Agriculture HAcCP Plans Food Safety and Inspection Service September 1999 HACCP-1
United States Department of Agriculture Food Safety and Inspection Service September 1999 HACCP-1 Guidebook for the Preparation of HACCP Plans
Additional copies of the Guidebook for the Preparation of HACCP Plans and the generic haccP Models are available from U.S. Department of Agriculture Food Safety and Inspection Service(FSis Office of Policy, Program Development, and Evaluation(OPPDE) Inspection Systems Development Division Room 202, Cotton Annex Building 300 12Street Sw Washington. D. C. 20250-3700 Phone:(202)720-3219 Fax:(202)690-0824 This material is also available on the fsis homepage http://www.fsisusdagov/index.htm
Additional copies of the Guidebook for the Preparation of HACCP Plans and the Generic HACCP Models are available from: U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) Office of Policy, Program Development, and Evaluation (OPPDE) Inspection Systems Development Division Room 202, Cotton Annex Building 300 12th Street SW Washington, D.C. 20250-3700 Phone: (202) 720-3219 Fax: (202) 690-0824 This material is also available on the FSIS Homepage: http://www.fsis.usda.gov/index.htm
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 SERVICES
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 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
designed to extend or further interpret existing regulations; rather, they are designed to send the user back to the regulations so he/she can become familiar with the requirements as well as the flexibility they permit. The generic models are not designed to present new or alternativ methods of producing and processing meat and poultry products. That is also left to others with an interest in doing so FSIS envisioned that the generic models might be used in the following way: Suppose a HACCI team leader of a three-person haCCP team in a very small establishment attended a training course, but the others on his/her team were not able to do so. Suppose the HaCCP training course met all the requirements of 417.7 but did not prons and answers, access to follow-up or ide participants with much in the w take away materials"like workbooks, practical questic resources, etc, which the Research Triangle Institute(RTi needs assessment indicated were so important to these establishments. The trained hacCp team leader returns to the establishment and begins the process of attempting to develop haCCp plans for the company's products and processes. He/she is quite confident that he/she has grasped the material presented in the training course and begins to work with this team immediately, while the concepts are fresh in his/her First he/she has the rest of the team review the Canadian video and the guidebook from FSiS so that all members of his team have a basic level of information The team members begin their work, and as they proceed, some questions arise as to whether what they have developed is appropriate. This is the point when FSIS expects the team to pick up the appropriate generic model and get a sense of whether they are on the right track. They should be able to determine whether the forms that they have developed, while different from the various ones in the generic models and not the same as what other companies use, are acceptable because they include the required information. They will also be able to discover what are some pical food safety hazards that are reasonably likely to occur, as explicitly defined in 417. 2, and how to think through the problems that these hazards represent for their own products. They can see how critical limits might arise from existing regulatory requirements like the ones for rapid chilling of poultry products. They can also see that in the absence of settled regulator requirements, there may be several sources of scientific expertise, and they can choose to make a conservative decision to provide a good margin of safety. They can find out the essential differences between monitoring and verification and have a basis for making their choices about erification activities and their frequencies. FSIS believes that these are useful, beneficial and worthwhile functions for which its generic models can be used FSIS is publishing these updated revisions of the generic models, beginning with the Guidebook and the Generic Model for Raw, Ground Product, because a large backlog of requests exists for these two documents. FSiS intends to publish revisions of all the generic models no later than September 30, 1999. Moreover, as a result of public consultation, it may publish an additional revision of some of these models, but given the backlog and the impending HACCP implementation date, we considered it important to get a version of these documents out now We hope that these documents are helpful
2 designed to extend or further interpret existing regulations; rather, they are designed to send the user back to the regulations so he/she can become familiar with the requirements as well as the flexibility they permit. The generic models are not designed to present new or alternative methods of producing and processing meat and poultry products. That is also left to others with an interest in doing so. FSIS envisioned that the generic models might be used in the following way: Suppose a HACCP team leader of a three-person HACCP team in a very small establishment attended a training course, but the others on his/her team were not able to do so. Suppose the HACCP training course met all the requirements of 417.7 but did not provide participants with much in the way of "take away materials" like workbooks, practical questions and answers, access to follow-up resources, etc., which the Research Triangle Institute (RTI) needs assessment indicated were so important to these establishments. The trained HACCP team leader returns to the establishment and begins the process of attempting to develop HACCP plans for the company's products and processes. He/she is quite confident that he/she has grasped the material presented in the training course and begins to work with this team immediately, while the concepts are fresh in his/her mind. First, he/she has the rest of the team review the Canadian video and the Guidebook from FSIS so that all members of his team have a basic level of information. The team members begin their work, and as they proceed, some questions arise as to whether what they have developed is appropriate. This is the point when FSIS expects the team to pick up the appropriate generic model and get a sense of whether they are on the right track. They should be able to determine whether the forms that they have developed, while different from the various ones in the generic models and not the same as what other companies use, are acceptable because they include the required information. They will also be able to discover what are some typical food safety hazards that are reasonably likely to occur, as explicitly defined in 417.2, and how to think through the problems that these hazards represent for their own products. They can see how critical limits might arise from existing regulatory requirements like the ones for rapid chilling of poultry products. They can also see that in the absence of settled regulatory requirements, there may be several sources of scientific expertise, and they can choose to make a conservative decision to provide a good margin of safety. They can find out the essential differences between monitoring and verification and have a basis for making their choices about verification activities and their frequencies. FSIS believes that these are useful, beneficial and worthwhile functions for which its generic models can be used. FSIS is publishing these updated revisions of the generic models, beginning with the Guidebook and the Generic Model for Raw, Ground Product, because a large backlog of requests exists for these two documents. FSIS intends to publish revisions of all the generic models no later than September 30, 1999. Moreover, as a result of public consultation, it may publish an additional revision of some of these models, but given the backlog and the impending HACCP implementation date, we considered it important to get a version of these documents out now. We hope that these documents are helpful
Guidebook Table of contents Introduction Developing a haccp plan Policy notices Preliminary Steps 1. Assemble the HACCP team, including one person who is HACCP-trained...5 2. Describe the food and its method of production and distribution 3. Develop and verify process flow diagram(s) 4. Decide whether products can be grouped using the process categories 7 PRINCIPLE I: CONDUCT A HAZARD ANALYSIS Biological hazards Chemical hazards Physical Hazards PRINCIPLE IL: IDENTIFY THE CRITICAL CONTROL POINTS PRINCIPLE III: ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT 11 PRINCIPLE IV: ESTABLISH MONITORING PROCEDURES PRINCIPLE V: ESTABLISH CORRECTIVE ACTIONS PRINCIPLE VI: ESTABLISH RECORDKEEPING PROCEDURES PRINCIPLE VIL: ESTABLISH VERIFICATION PROCEDURES Validation Ongoing verification 15 ATTACHMENTS Attachment 1- PRODUCT DESCRIPTION 17 Attachment 2-PROCESS FLOW DIAGRAM (Raw product-ground).....18
Guidebook Table of Contents Introduction………………………………………………………………………………. 3 Developing a HACCP Plan..………………………………………………………….….. 3 Policy Notices………………………………….…………………………………………. 4 Preliminary Steps..………………………………………………………………………… 5 1. Assemble the HACCP team, including one person who is HACCP-trained…… 5 2. Describe the food and its method of production and distribution………………. 6 3. Develop and verify process flow diagram(s)…………………………………….6 4. Decide whether products can be grouped using the process categories………… 7 PRINCIPLE I: CONDUCT A HAZARD ANALYSIS…………………..……………….. 8 Biological Hazards………………………………………………………………… 8 Chemical Hazards…………………………………………………………………. 8 Physical Hazards…………………………………………………………………... 9 PRINCIPLE II: IDENTIFY THE CRITICAL CONTROL POINTS.…………….………. 10 PRINCIPLE III: ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT……….……………………………………………... 11 PRINCIPLE IV: ESTABLISH MONITORING PROCEDURES……………………….... 12 PRINCIPLE V: ESTABLISH CORRECTIVE ACTIONS……………………………….. 13 PRINCIPLE VI: ESTABLISH RECORDKEEPING PROCEDURES……………….…… 14 PRINCIPLE VII: ESTABLISH VERIFICATION PROCEDURES…………………….… 15 Validation………………………………………………………………………….. 15 Ongoing verification……………………………………………………………….. 15 Reassessment………………………………………………………………………. 15 ATTACHMENTS Attachment 1 – PRODUCT DESCRIPTION……………………………………… 17 Attachment 2 – PROCESS FLOW DIAGRAM (Raw product-ground)……………18 1