HACCP Systems Validation, 32184-32191 [2013-12763]

Download as PDF 32184 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Proposed Rules in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming. Ms. Meredith C. Jones, Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737–1231; (301) 851– 2289. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: On January 30, 2013, we published in the Federal Register (78 FR 6222–6227, Docket No. APHIS–2012–0002), a proposal 1 to amend the fruits and vegetables regulations to allow the importation of avocados from continental Spain (excluding the Balearic Islands and Canary Islands) into the United States subject to a systems approach and treatment. Comments on the proposed rule were required to be received on or before April 1, 2013. We are reopening the comment period on Docket No. APHIS– 2012–0002 for an additional 15 days. This action will allow interested persons additional time to prepare and submit comments. We will also accept comments received between April 2, 2013 (the day after the close of the original comment period) and the date of this notice. Authority: 7 U.S.C. 450, 7701–7772, and 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. Done in Washington, DC, this 22nd day of May 2013. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2013–12679 Filed 5–28–13; 8:45 am] tkelley on DSK3SPTVN1PROD with PROPOSALS BILLING CODE 3410–34–P 1 To view the proposed rule, risk documents, and the comments we received, go to http:// www.regulations.gov/#!docketDetail;D=APHIS2012-0002. 17:56 May 28, 2013 Jkt 229001 Animal and Plant Health Inspection Service 7 CFR Part 319 [Docket No. APHIS–2011–0132] RIN 0579–AD62 Importation of Fresh Apricots From Continental Spain Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule; reopening of comment period. AGENCY: We are reopening the comment period for our proposed rule that would allow the importation into the United States of fresh apricots from continental Spain. This action will allow interested persons additional time to prepare and submit comments. DATES: The comment period for the proposed rule published January 30, 2013 (78 FR 6227) is reopened. We will consider all comments that we receive on or before June 13, 2013. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov/ #!documentDetail;D=APHIS-2011-01320001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2011–0132, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Supporting documents and any comments we receive on this docket may be viewed at http:// www.regulations.gov/ #!docketDetail;D=APHIS-2011-0132 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming. FOR FURTHER INFORMATION CONTACT: Ms. Meredith C. Jones, Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737–1231; (301) 851– 2289. SUPPLEMENTARY INFORMATION: On January 30, 2013, we published in the Federal Register (78 FR 6227–6232, Docket No. APHIS–2011–0132) a SUMMARY: Background VerDate Mar<15>2010 DEPARTMENT OF AGRICULTURE PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 proposal 1 to amend the regulations concerning the importation of fruits and vegetables to allow the importation of fresh apricots from continental Spain into the United States subject to a systems approach jointly agreed upon in a bilateral workplan between APHIS and the national plant protection organization of Spain. Comments on the proposed rule were required to be received on or before April 1, 2013. We are reopening the comment period on Docket No. APHIS– 2011–0132 for an additional 15 days. This action will allow interested persons additional time to prepare and submit comments. We will also consider all comments received between April 2, 2013 (the day after the close of the original comment period) and the date of this notice. Authority: 7 U.S.C. 450, 7701–7772, and 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. Done in Washington, DC, this 22nd day of May 2013. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2013–12685 Filed 5–28–13; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR part 417 [Docket No. FSIS–2009–0019] HACCP Systems Validation Food Safety and Inspection Service, USDA. ACTION: Notice of public meeting and request for comments. AGENCY: The Food Safety and Inspection Service (FSIS) is announcing the availability of updated guidance for Hazard Analysis Critical Control Point (HACCP) systems validation. In addition, FSIS is announcing that it will hold a public meeting on June 25, 2013, to review changes to the guidance announced in this notice and to take comments. The public meeting will also be available by teleconference. Following the public meeting, the Agency will accept written comments until July 25, 2013. Given the extensive opportunity for comment on the guidance, however, the Agency believes SUMMARY: 1 To view the proposed rule, risk documents, and the comments we received, go to http:// www.regulations.gov/#!docketDetail;D=APHIS2011-0132. E:\FR\FM\29MYP1.SGM 29MYP1 tkelley on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Proposed Rules that very few, if any, issues remain in this proceeding. DATES: The public meeting will be held on June 25, 2013 from 8:30 a.m. to 12:30 p.m. On-site registration will begin at 8:00 a.m. Written comments may be submitted until July 25, 2013. ADDRESSES: The public meeting will be held in the 1st Floor Auditorium of Patriots Plaza 3, 355 E Street SW., Washington, DC 20024. FSIS will finalize the agenda by June 18, 2013 and post it on the FSIS Web page at: http://www.fsis.usda.gov/ News_&_Events/meetings_&_events/ index.asp. Registration: Pre-registration is recommended. To pre-register, access the FSIS Web site at http:// www.fsis.usda.gov/News_&_Events/ meetings_&_events/index.asp. Call-in information will be provided via email to pre-registered participants. If you are interested in making a public comment during the teleconference, please indicate so on the registration form. In addition to the public meeting, interested persons may submit comments using either of the following methods: • Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for submitting comments. • Mail, including CD–ROMs, etc.: Send to Docket Clerk, U.S. Department of Agriculture (USDA), FSIS, OPPD, RIMS, Patriots Plaza 3, 1400 Independence Avenue SW., Mail Stop 3782, Room 8–163A, Washington, DC 20250–3700. • Hand- or Courier-Delivered Submittals: Deliver to Patriots Plaza 3, 355 E Street SW., Room 8–163A, Washington, DC 20024. Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS– 2009–0019. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to http:// www.regulations.gov. Docket: For access to background documents or comments received, go to the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: William K. Shaw, Jr., Ph.D., Office of Policy and Program Development, FSIS, USDA, 1400 Independence Avenue SW., Patriots Plaza 3, Mailstop 3782, VerDate Mar<15>2010 17:56 May 28, 2013 Jkt 229001 Room 8–142, Washington, DC 20250. Telephone: (301) 504–0852 Fax: (202)245–4792. E-Mail: william.shaw@fsis.usda.gov. Background FSIS administers the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to protect the health and welfare of consumers by preventing the distribution in commerce of meat or poultry products that are unwholesome, adulterated, or misbranded. To reduce the risk of foodborne illness from meat or poultry products, FSIS issued regulations on July 25, 1996, which require that federally inspected establishments adopt HACCP systems (61 FR 38806). These regulations require that federally inspected establishments adopt measures to prevent or control the occurrence of food safety hazards at each stage of the production process where such hazards are reasonably likely to occur. In the May 9, 2012 Federal Register (77 FR 27135), FSIS issued a notice to clarify its requirements for validation by an establishment of its HACCP system and to announce the availability of the draft guidance on validation, which is discussed in more detail below. The HACCP regulations in 9 CFR part 417 require that establishments validate the HACCP plan’s adequacy to control the food safety hazards identified by the hazard analysis (9 CFR 417.4(a)). These regulations prescribe requirements for the initial validation of an establishment’s HACCP plan and require establishments to ‘‘conduct activities designed to determine that the HACCP plan is functioning as intended.’’ During this initial validation period, establishments are to ‘‘repeatedly test the adequacy of the CCPs, critical limits, monitoring and recordkeeping procedures, and corrective actions’’ prescribed in their HACCP plans (9 CFR 417.4(a)(1)). As FSIS explained in the May 9, 2012 Federal Register, validation under 9 CFR 417.4(a)(1) requires that establishments assemble two types of data: 1) the scientific or technical support for the judgments made in designing the HACCP system, and 2) evidence derived from the HACCP plan in operation to demonstrate that the establishment is able to implement the critical operational parameters necessary to achieve the results documented in the scientific or technical support. The regulations also provide that ‘‘[v]alidation . . . encompasses reviews of the records themselves, routinely PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 32185 generated by the HACCP system, in the context of other validation activities’’ (9 CFR 417.4(a)(1)). As FSIS explained in the May 9, 2012 Federal Register, if an establishment’s supporting documentation for its hazard analysis includes records associated with a prerequisite program that provides for an intervention or process designed to prevent a hazard from being likely to occur, the establishment’s validation records would need to include all documents associated with the prerequisite program. Thus, validation of the HACCP system involves validation of the critical control points in the HACCP plan, as well as of any interventions or processes used to support decisions in the hazard analysis. Initial Draft Guidance In March 2010, FSIS posted on its Web site an initial draft guidance document to assist the industry, particularly small and very small establishments, in complying with the requirements for HACCP systems, pursuant to 9 CFR 417.4. On June 14, 2010, FSIS held a public meeting to discuss the initial draft HACCP validation guidance and received input from stakeholders. The transcript of the June 2010 public meeting is available on the FSIS Web site at: http://www.fsis.usda.gov/PDF/ Transcripts_HACCP_Validation_ 061410.pdf. FSIS received over 2,000 comments on the initial draft guidance, particularly with respect to the use of microbiological testing to validate the effectiveness of HACCP systems in controlling biological hazards. The Agency considered the issues raised by the comments received in response to the May 2010 Federal Register notice and at the June 2010 public meeting and developed updated second draft compliance guidance. On September 22–23, 2011, FSIS shared a second draft of the HACCP validation guidance with the National Advisory Committee on Meat and Poultry Inspection (NACMPI). The Committee reviewed the draft and provided comments and suggestions to FSIS on how to improve the guidance. The NACMPI report is available on the FSIS Web site at: http:// www.fsis.usda.gov/PDF/Validation_ Issue_Paper_Final.pdf. The Agency made additional revisions to the draft guidance in response to the input from NACMPI. In a May 9, 2012 Federal Register notice, FSIS announced the availability of, and requested comments on, the revised draft guidance document E:\FR\FM\29MYP1.SGM 29MYP1 32186 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Proposed Rules (http://www.fsis.usda.gov/OPPDE/rdad/ FRPubs/2009-0019.htm). In the May 2012 Federal Register notice, the Agency also clarified its requirements for HACCP system validation and responded to the comments that it had received on the initial draft guidance. The May 2012 Federal Register notice explained that the Agency was soliciting comments on the revised draft, and that it would hold another public meeting before issuing final guidance for HACCP systems validation (77 FR 27135). tkelley on DSK3SPTVN1PROD with PROPOSALS Comments on the Guidance FSIS received fifty-one (51) comments on its May 2012 revised draft guidance on HACCP validation from small and very small meat or poultry processors, trade associations representing animal producers, small business owners, corporations, State Departments of Agriculture, and consumer advocacy organizations. FSIS has carefully considered the comments and has revised its draft guidance in light of these comments. The following is a brief summary and discussion of the major issues raised in the comments to the draft guidance document. 1. Concerns About Validation, Its Applicability, and Cost Comment: Several commenters asked why the validation guidance or new FSIS enforcement of validation requirements is necessary, especially given the amount of time the HACCP regulations have been in place. These commenters stated that establishments should not have to ‘‘revalidate’’ their systems. Response: The validation guidance is necessary because the Agency found that establishments have not adequately validated their systems. During the process of developing the draft guidance, FSIS added an appendix to the document that explains the need for validation and FSIS’s experiences that led it to create the guidance document (e.g., FSIS’s findings following a 2011 Lebanon bologna outbreak that the establishment’s scientific support on file did not match the process the establishment was using to make the bologna; non-O157 positives in 2012 that FSIS concluded likely occurred because of improperly designed interventions; and the chicken pot pie outbreaks in 2007 that FSIS concluded may have occurred because of improperly validated cooking instructions). Based on findings from FSIS’s data analyses and outbreak investigations, the Agency recommends that establishments use the guidance document to ensure that their HACCP VerDate Mar<15>2010 17:56 May 28, 2013 Jkt 229001 systems are properly validated. On an annual basis, and whenever changes occur that affect the hazard analysis of the HACCP plan, the establishment should conduct a reassessment as required in 9 CFR 417.4(a)(3) (i.e., review records generated over the course of the previous year, or during the period the change occurred, that reflect how the HACCP system is performing as a whole and analyze them to determine whether food safety goals are being met). If the reassessment shows that the HACCP system is effective and functioning as intended, the establishment can consider continuing on with the same system and the same monitoring and verification procedures and frequencies. If reassessment shows that either their HACCP system was not set up correctly, is not being implemented consistently, or is no longer effective, the establishment would make changes to its HACCP system (e.g., add another intervention) and then would, in most cases, be required to validate any changes to its HACCP system. While most establishments have assembled the scientific or technical documentation needed to support their HACCP systems, many establishments have not gathered the necessary in-plant validation data demonstrating that their HACCP systems are functioning as intended, which is why the guidance document is necessary. As is explained below, in approximately six months from the time that FSIS issues the final validation guidance, FSIS intends to begin verifying that establishments comply with all validation requirements. Comment: Several commenters expressed concern about the cost of validation, particularly for small establishments that have many different HACCP plans. One comment stated that if a very small establishment cannot afford to comply with validation requirements, it should have the option to return to ‘‘conventional’’ inspection instead of HACCP. Commenters were also concerned about the costs of obtaining in-plant microbial data and other costs associated with validation. Response: HACCP was implemented in 1996 and has resulted in great improvements in food safety. The Agency is not going back to a command and control inspection approach because it would not provide establishments with the flexibility to design innovative systems that ensure food safety. In the guidance, FSIS states that microbiological testing is needed for inplant data in only limited circumstances PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 and has provided low cost ways in which establishments can validate their systems in place of microbiological testing, such as ensuring that they are meeting the critical operating parameters of the interventions as defined in the scientific support. Therefore, FSIS estimates that costs associated with meeting validation requirements will be minimal. Comment: Several commenters stated that establishments should not have to validate their prerequisite programs because 9 CFR 417.4(a)(1) does not apply to prerequisite programs. One commenter recommended that, in the absence of a CCP, prerequisite programs referenced in the flow chart should be validated, but that otherwise, establishments should not be required to validate their prerequisite programs. The same commenter also requested that FSIS begin only reviewing validation for CCPs and then, at a later date, begin reviewing validation for prerequisite programs referenced in the flow chart. One commenter stated that only prerequisite programs that contain scientifically supported critical operating parameters (e.g., foreign material control, Good Manufacturing Practices, employee hygiene) should have to be validated. Several commenters stated that they needed guidance concerning how to validate pest control, employee hygiene, sanitation practices, and other processes. Response: Validation is the process of demonstrating that the HACCP system, as designed, can adequately control identified hazards to produce a safe, unadulterated product. Prerequisite programs designed to support a decision in the hazard analysis are part of the HACCP system. When an establishment determines that a hazard is not reasonably likely to occur because the prerequisite program prevents the hazard, that prerequisite program becomes part of the HACCP system. Therefore, prerequisite programs designed to support decisions in the hazard analysis (e.g. Sanitation Standard Operating Procedures (Sanitation SOPs), purchase specifications, antimicrobial interventions) need to be validated to ensure that the overall system can operate effectively. Even though 9 CFR 417.4(a)(1) does not refer to Sanitation SOPs or other prerequisite programs, establishments’ initial validation activities need to include employee hygiene and other similar prerequisite programs if they are used to support decisions in the hazard analysis. As explained in the guidance, in order to validate such programs, establishments E:\FR\FM\29MYP1.SGM 29MYP1 tkelley on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Proposed Rules need to provide scientific documentation that supports that they will work as intended and to collect inplant data to support that the programs can be implemented as designed. Comment: Some commenters stated that establishments should not be required to validate cooking instructions because the cooking is performed by the consumer. One comment stated that discussion of validating the time and temperature combinations for cooking instructions should be removed from the guidance. Another commenter requested more guidance on how establishments should validate cooking instructions. Another commenter asked for confirmation that validated cooking instructions are not considered a CCP. Response: An establishment must validate all measures that it relies upon to prevent or control the hazards that it has identified in its HACCP system, whether the measures are part of the HACCP plan itself or part of a program that includes measures that affect the hazard analysis. Thus, if an establishment’s HACCP system includes cooking instructions as a measure to address a potential food safety hazard after entry into the establishment, the establishment must properly validate the instructions. As we saw in the 2007 salmonellosis outbreak associated with chicken pot pies, providing cooking instructions on a package that cannot be repeated by the consumer represents an increased risk to the consumer. Had the establishment validated the cooking instructions on the pot pies to ensure they would achieve the desired endpoint temperature under actual consumer cooking conditions, these illnesses may have been prevented (http:// www.cdc.gov/mmwr/preview/ mmwrhtml/mm5747a3.htm). If an establishment’s HACCP system includes placing cooking instructions on the product’s label, the instructions must be validated to ensure that consumers who follow the instructions will achieve the endpoint time/ temperature needed to ensure that the product is cooked and safe to consume. While validated cooking instructions may be used as a control to address hazards that may occur after the product has left the establishment, the establishment is still required to address food safety hazards that are reasonably likely to occur in the production process and identify the measures the establishment can apply to control those hazards (9 CFR 417.2(a)(1). http:// www.cdc.gov/mmwr/preview/ mmwrhtml/mm5747a3.htm). FSIS is in the process of developing a guidance document on validating VerDate Mar<15>2010 17:56 May 28, 2013 Jkt 229001 cooking instructions for mechanically tenderized beef product. FSIS has previously recommended validated cooking instructions for product that appears to be ready-to-eat, but its meat or poultry components have not received a sufficient lethality step or some other component has not received a lethality step. http:// www.fsis.usda.gov/OPPDE/rdad/FSIS Directives/10240.4/Resource_1.pdf Resource 1 for NRTE products that appear to be RTE (e.g., entrees, dinners, casseroles etc) http://www.fsis.usda.gov/ PDF/Info_on_Validation_of_Labeled_ Cooking_Instructions_Raw_or_Partially_ Cooked_Poultry.pdf (validated cooking instructions) http://www.fsis.usda.gov/ PDF/Labeling_Policy_Guidance_ Uncooked_Breaded_Boneless_Poultry_ Products.pdf (this link includes the background information and Q&As) Comment: Several comments stated that establishments should not be required to collect in-plant data for more than one product in a HACCP process category. These commenters also requested guidance on how to select a product from within each HACCP category. Commenters noted that such in-plant data would include execution data for all CCPs, interventions, and prerequisite programs used to support decisions in the hazard analysis. One commenter questioned whether the establishment would need to validate the food safety system for each product if the only difference among products is a seasoning. Another commenter stated that it is possible to have in-plant data for product of one species within a HACCP category serve as in-plant data to validate the process for product from another species if there are no additional food safety concerns. Another commenter stated that FSIS’s guidance should follow the NACMPI recommendations to group typical products into categories and select ‘‘worst case products’’ within the group. Response: In the revised guidance, FSIS has clarified that establishments are not required to collect in-plant data for more than one product within a HACCP process category. The guidance now provides information concerning how establishments should select a product from within a HACCP category. The guidance also provides information on how establishments can develop a decision-making document concerning product choices for collecting in-plant data. The guidance provides examples of how to collect in-plant data to aid industry, but establishments will have the flexibility to develop their own criteria. PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 32187 Comment: A few commenters requested confirmation that establishments would not have to conduct ‘‘initial’’ validation for all changes that result from reassessment. Several commenters asked whether the whole system would need to be validated or just a change following reassessment. One commenter stated that improved implementation of a HACCP system would not necessarily result in changes to the design of the system. Response: Establishments do not need to conduct validation of the whole system for all changes that result from reassessment. Depending on the change, the establishment will likely only need to validate that the change is functioning as intended. For example, an establishment may change the thickness of a raw patty product and determine that it only needs to validate that the cooking instructions still achieve the desired endpoint temperature at the new product thickness. In this example, the establishment would not need to validate the entire HACCP system. Comment: Several commenters stated that very small establishments that produce products infrequently cannot obtain 13 production days worth of records within 90 calendar days. One commenter suggested extending the validation period beyond 90 calendar days in order to obtain 13 days worth of records. Another commenter requested that the guidance document clarify that large establishments have the flexibility to determine whether there are a sufficient number of production days within the 90 calendarday period to gather appropriate data. Response: The guidance explains that for large establishments, 90 calendar days equates to approximately 60 production days. FSIS recognizes that many small and very small establishments do not operate daily. Therefore, the guidance also states that 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. The establishment should consider focusing validation activities on the product produced most frequently within each HACCP category. In the guidance, FSIS recognizes that there are some establishments that produce products so infrequently that they would not be able to gather records from 13 production days within those 90 initial calendar days. If the establishment infrequently produces several products that are each part of a separate HACCP category, there is E:\FR\FM\29MYP1.SGM 29MYP1 32188 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS inherent risk with the processes if the establishment does not have experience in producing them. Therefore, to determine whether the system is properly designed and executed, even though the regulations provide 90 days for a conditional grant of inspection (9 CFR 304.3(b)), an establishment needing more than 90 days can ask the District Office, in writing, for additional time to collect at least 13 production days of records. The guidance explains that establishments may also consider evaluating data collected for products across multiple HACCP categories that share some common steps, ingredients, or equipment, to determine whether the data together can support its ability to meet critical operational parameters. Scientific Support Comment: Appendix A of the final rule, ‘‘Performance Standards for the Production of Certain Meat and Poultry Products’’ (64 FR 746–748) is specific to Salmonella but is often used to support lethality of other pathogens, such as E. coli O157:H7 and Lm. Therefore, several commenters asked whether establishments could use Appendix A as scientific support for process controls for pathogens other than Salmonella. Response: FSIS has revised the validation guidance to clarify that during slaughter, in order to be most effective, it is very important that interventions have been studied for the pathogen and product pair of interest. In addition, FSIS has clarified that for thermal processing treatments, Salmonella can be used as an indicator for other pathogens of concern. Therefore, Appendix A can be used as scientific justification for the process without further support that the results apply to other pathogens such as E. coli O157:H7 or Lm. Comment: Some commenters questioned whether their scientific support must be peer-reviewed. One commenter asked whether a processing authority could be an establishment owner with knowledge of the process. The commenter also asked if it could use documents that only provide a critical limit as scientific support (for example, a University publication or a textbook with growth limits of bacteria). Response: FSIS has revised the guidance to clarify that the Agency recommends peer-reviewed scientific data to support the process used, but does not require peer-reviewed data. An establishment may use peer-reviewed scientific data or information in addition to a scientific article from a peer-reviewed journal as scientific support for its processes. Such information would include data from a VerDate Mar<15>2010 17:56 May 28, 2013 Jkt 229001 textbook on the growth limits of certain pathogens, based on a food product’s water activity and pH. This information could be used as scientific support because information in scientific textbooks has generally been peerreviewed. Peer-reviewed scientific data goes through a process of evaluation involving qualified individuals within the relevant field that ensures the integrity of the data. Scientific data that is not peerreviewed is less reliable than peerreviewed data, because there could be flaws in the science that a peer review would have revealed. If an establishment uses scientific data that is not peer-reviewed, the establishment may be subject to additional scrutiny by Agency personnel performing verification activities. An establishment may rely on a process authority to provide necessary scientific support for the establishment’s process. As stated above, to meet validation requirements, the establishment is required to ensure that the scientific data and documentation provided by the processing authority supports that the process addresses the identified hazards, and meets the expectations for validation requirements. Comment: Several commenters stated that the guidance document is still too vague in terms of how close the scientific support needs to match an actual process. For example, commenters asked whether the manufacturer of a grinder would have to be the same as the grinder used in a supporting study. Commenters also asked how significant casing size differences among the process used and support studies would need to be before the support document would no longer apply. Commenters stated that parameters are often more controlled during research than in-plant, and that it is costly for establishments to measure temperature and pounds per square inch. Response: In the guidance, FSIS has clarified how scientific support should match an actual process. Generally, establishments should use the same critical operational parameters as those in the support documents. In some circumstances, establishments may be able to support using critical operational parameters that are different from those in the support documents (e.g., higher concentrations of antimicrobials or higher thermal processing temperatures). In these cases, establishments should provide justification supporting that the levels chosen are at least as effective as those in the support documents. This PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 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. Similarly, higher processing temperatures may result in the surface of the product drying out before adequate lethality is achieved. Establishments also need to ensure the levels are safe and suitable (http:// www.fsis.usda.gov/OPPDE/rdad/ FSISDirectives/7120.1.pdf and 9 CFR 424.21(c)). Comment: Several commenters stated that FSIS Notice 36–12 (http:// www.fsis.usda.gov/oppde/rdad/ FSISNotices/36-12.pdf) suggested that the challenge study establishments used in the case of the Lebanon bologna would not be adequate support because the critical operational parameters in the study did not match those used in the establishment. Response: The FSIS notice on Lebanon bologna explained that the actual process that the establishment used did not match the scientific support. As a result, the establishment’s process did not achieve adequate lethality. Establishments producing Lebanon bologna can use the guidance as scientific support; however, they need to ensure that their process meets the critical operating parameters used in the study. FSIS recognizes that scientific support performed in a laboratory may not always match an establishment’s exact parameters. However, significant differences, such as the permeability of the casing used or the diameter of the product, are key factors that affect lethality and therefore cannot be overlooked. For instance, if an establishment wants to use a permeable casing, the establishment cannot assume that its process will achieve the same reduction in pathogens as achieved in a study using an impermeable casing. Comment: Some comments stated that discussion of critical operational parameters in the guidance will lead some to conclude that all parameters are critical. Several commenters requested that FSIS create a third party or consortium to help establishments identify scientific support and critical operational parameters. Another commenter requested that FSIS’s guidance address validation and scientific support for additional hazards, such as viruses and protozoa. Several commenters stated that establishments do not have the expertise to scientifically support or identify critical operational parameters. One commenter stated that establishments E:\FR\FM\29MYP1.SGM 29MYP1 tkelley on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Proposed Rules do not know how to test parameters of the different processes. Response: Critical operational parameters are the specific conditions that the intervention must operate under in order for it to be effective. The guidance document explains in detail how an establishment can identify the critical operational parameters in its scientific support. Specifically, Appendix 3, provides step-by-step guidance to establishments. FSIS will continue to post commonly cited journal articles on its Web site in which critical operational parameters have been identified and will offer support through askFSIS to establishments trying to identify critical operational parameters. Comment: One commenter requested that reference to Purac’s modeling program be made within the guidance, and that the guidance address the use of pathogen modeling programs as scientific supporting documentation. The commenter also requested an additional example in the guidance to show how an establishment could validate the effectiveness of an antimicrobial agent through pathogen modeling. Response: FSIS has added a reference to pathogen modeling as a type of scientific support. In addition, FSIS has added an example in Appendix 3 to show how an establishment can validate its stabilization process through pathogen modeling. FSIS does not advocate certain programs and therefore did not cite Purac in the guidance. Comment: One commenter requested a listing of surrogate or indicator organisms that can be used for validation. Another commenter requested clarification on when establishments can use scientific support based on indicator organisms. Response: As explained in the guidance document, establishments should not rely on scientific support containing data from indicator or surrogate organisms unless available data establishes a relationship between the presence or level of a pathogen or toxin and the indicator organism. Such data can be collected from in-laboratory studies using indicator organisms that parallel the data in a challenge study performed with the inoculated pathogen. This data could be collected in the same way in which the pathogen is being tested or in another study performed under similar conditions. If similar and consistent reduction or control can be established, then control of the indicator organisms can be reliably used to indicate expected pathogen control in actual application in-plant. VerDate Mar<15>2010 17:56 May 28, 2013 Jkt 229001 2. Validation Worksheet Examples Comment: One commenter stated that FSIS should include an explanation of how the validation worksheet examples can be used. Another commenter recommended that the guidance state that establishments have flexibility to utilize approaches other than those in the worksheet examples. Two commenters recommended that FSIS recognize in the guidance that not all critical operational parameters identified in the Appendix will apply to all processes. Another commenter requested more detail be provided in the worksheet examples in terms of formatting and the types of data that establishments should collect. One comment stated that establishments’ environmental monitoring verifies that the Sanitation SOPs are working as intended, but does not validate them. Response: In the guidance document, FSIS has added numerous validation worksheet examples to illustrate how an establishment may want to display its own in-plant validation data. As FSIS explains in the guidance, the validation worksheet examples are for illustration purposes only and are included to help establishments to understand the types of scientific support and in-plant documentation that are needed to comply with the validation requirements. With regard to the comment on the Sanitation SOP monitoring, FSIS included this data in the guidance as an example of data collected during the initial 90 days of the set-up of a new program. Scientific support is needed to support the frequency of testing (which would address the factors used to determine the frequency). In-plant validation data is needed to support that the testing is adequate. 3. Microbiological Testing Comment: One comment asked for clarification as to whether samples need to be collected for each and every process, product, or species, and whether establishments would need to collect 13 samples for every product produced, as in the regulations that require establishments to conduct testing for generic E. coli (9 CFR 310.25 and 381.94) Response: If an establishment’s scientific support contains microbiological data showing the efficacy of the intervention against the identified food safety hazard, then the in-plant data does not need to include sampling. In that case, the in-plant data should support that the establishment PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 32189 follows the critical operational parameters from the study. Agency Training and Implementation Comment: Commenters stated that FSIS should ensure that inspection program personnel consistently verify and enforce validation requirements. One commenter stated that FSIS should share training for FSIS personnel with industry. A commenter also recommended that FSIS hold regional sessions to communicate the policy to establishments, and that the Agency engage cooperative extension programs in its communication strategy. One commenter recommended that the Agency create a tutorial on understanding scientific articles and on identifying critical operational parameters. Commenters also requested that FSIS issue a notice or directive explaining how inspectors should use the validation guideline. A few commenters requested that FSIS phase-in verification of validation requirements based on risk or product categories, rather than establishment size. One commenter requested an additional six months to gather validation documents before FSIS begins new verification activities related to validation. Response: The guidance is meant for establishments. FSIS will ensure inspection program personnel understand validation requirements and will issue necessary instructions to field personnel so that they are aware of the final guidance and share it with establishments. FSIS will also issue necessary instructions to field personnel for them to verify that establishments meet all validation requirements. FSIS will implement its new verification activities by phasing them in based on establishment size. For large establishments, the agency plans to wait approximately six months from the date that the final guidance is issued to start verifying and enforcing the second element of validation (initial in-plant validation). Thus, large establishments will have six months from the date that the final guidance is issued to gather all necessary in-plant demonstration documents. FSIS intends to begin verifying that small and very small establishments meet all validation requirements nine months from the date the final guidance is issued. Therefore, these establishments will have approximately nine months from the date the final guidance is issued to gather all necessary in-plant demonstration documents before FSIS will verify and E:\FR\FM\29MYP1.SGM 29MYP1 32190 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Proposed Rules enforce the second element of validation. tkelley on DSK3SPTVN1PROD with PROPOSALS Other Changes to Validation Guidance Examples: The guidance contains additional examples of food safety problems linked to inadequate validation and recommendations to aid establishments in meeting initial validation requirements. These examples demonstrate the need for validation and provide support for recommendations made within the guidance. Scientific Support Documents. FSIS has added a section to the guidance that explains to establishments how to determine whether scientific support documents are sufficiently related to the process, product, and hazard identified in the hazard analysis to constitute appropriate validation. The guidance explains that the supporting documentation should identify the hazard (biological, physical, and chemical), the expected level of hazard reduction or prevention to be achieved, all critical operational parameters or conditions necessary to address the hazard, the processing steps that will achieve the specified reduction or prevention, and how these processing steps can be monitored. FSIS has also included information on how establishments can identify supporting documentation that adequately addresses the expected level of hazard or reduction or prevention to be achieved. FSIS provided examples for biological, physical, and chemical hazards that should aid establishments in ensuring that the scientific support closely matches the hazard being controlled. FSIS has also clarified when establishments may use scientific support containing data from indicator or surrogate organisms. Critical Operational Parameters. The guidance continues to state that critical operational parameters are those necessary for interventions to be effective and explains how an establishment can identify the critical operational parameters in its scientific support. As discussed above in response to comments, establishments generally should use the same critical operational parameters as those in the support documents. However, in some circumstances, establishments may be able to support using critical operational parameters that are different from those in the support documents (e.g., higher concentrations of antimicrobials or higher thermal processing temperatures). In these cases, establishments should provide justification supporting that the levels VerDate Mar<15>2010 17:56 May 28, 2013 Jkt 229001 chosen are at least as effective as those in the support documents. FSIS has added an additional Appendix (Appendix 2) to provide an example of a decision-making document an establishment could develop when it uses different levels of a critical operational parameter than the parameters in the support document. An establishment may use the decisionmaking document to explain the scientific rationale for why it is using critical operational parameters that are different from those in the support documents. In-plant data. The guidance recommends that establishments collect in-plant validation data for a wide variety of products and worst case scenarios. Appendix 4 of the guidance contains validation worksheet examples that establishments may reference to help them understand the types of scientific support and in-plant documentation that are needed to comply with the validation requirements. Initial validation vs. on-going verification. The guidance explains the differences between initial validation and on-going verification and the relationship between the activities performed to provide initial validation as opposed to on-going verification. The revised guidance also clarifies when changes that result from reassessment would not require validation. For example, an establishment may need to reassess its HACCP system following a change in supplier of a raw material, but the change would not require validation if the establishment determines that the composition of the raw material and microbiological profile are not significantly different from the material provided by the previous supplier. In other cases, changes that result from the reassessment would not require additional scientific support but would require additional in-plant demonstration data. For example, an establishment may find through reassessment that the design of an intervention was adequate, but that its employees are not implementing the intervention correctly. In that case, the establishment would only need to collect in-plant data to demonstrate that the intervention could be implemented appropriately. Depending on the change, the establishment would likely only need to validate that the change is functioning as intended and not the entire HACCP system. The current draft of the compliance guide is available for public viewing in the FSIS docket room and on the FSIS Web site at http:// www.fsis.usda.gov/ Significant_Guidance/index.asp. PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 Public Meeting On June 25, 2013, the Agency will hold a public meeting to review the information presented in this document and accept comments. Next Steps Following the public meeting, the Agency will accept public comment for 30 days. Given the extensive opportunity for public comment on the compliance guide, it is likely that there are very few, if any, remaining issues. Therefore, FSIS does not foresee granting an extension to this final 30 day comment period. As soon as possible after the comment period ends, the Agency will issue a Federal Register notice announcing the final guidance and will post the final guidance to its Web page. FSIS will implement its new verification activities phased in by establishment size. As stated above, for large establishments, the Agency plans to delay verification of the second element of validation as part of its inspection activities for approximately six months from the date the final guidance is posted. For small and very small establishments, the Agency plans to delay implementation for approximately nine months from the date the final guidance is posted. Until FSIS begins enforcing all validation requirements, FSIS inspection personnel will continue to issue noncompliance records (NRs) if an establishment lacks the required scientific or technical support for its HACCP system, or if the scientific or technical support is inadequate. FSIS will continue to issue a Notice of Intended Enforcement if, taken together with other relevant findings, an establishment’s scientific or technical support is inadequate, and the Agency can support a determination that the establishment’s HACCP system is inadequate for any of the reasons provided in 9 CFR 417.6. Moreover, if, in conducting a Food Safety Assessment (FSA), an Enforcement, Investigations, and Analysis Officer (EIAO) finds that an establishment has not collected in-plant data to demonstrate that its HACCP process works as intended, the EIAO will note this finding in the FSA and inform the establishment. Until FSIS begins enforcing the in-plant data requirements, FSIS will not issue NRs or take enforcement actions based solely on a finding that an establishment lacks in-plant validation data. Additional Public Notification FSIS will announce this notice online through the FSIS Web page located at E:\FR\FM\29MYP1.SGM 29MYP1 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Proposed Rules http://www.fsis.usda.gov/ regulations_&_policies/ Federal_Register_Notices/index.asp. FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/ News_&_Events/Email_Subscription/. Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. USDA Nondiscrimination Statement tkelley on DSK3SPTVN1PROD with PROPOSALS USDA prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, or audiotape.) should contact USDA’s Target Center at (202) 720–2600 (voice and TTY). To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250–9410 or call (202) 720–5964 (voice and TTY). USDA is an equal opportunity provider and employer. Done at Washington, DC on May 23, 2013. Alfred V. Almanza, Administrator. [FR Doc. 2013–12763 Filed 5–24–13; 8:45 am] BILLING CODE 3410–DM–P VerDate Mar<15>2010 17:56 May 28, 2013 Jkt 229001 NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Parts 703, 715, and 741 RIN 3133–AD90 Derivatives National Credit Union Administration (NCUA). ACTION: Proposed Rule. AGENCY: This proposed rule permits credit unions to engage in limited derivatives activities for the purpose of mitigating interest rate risk. This proposed rule applies to federal credit unions and any federally insured, statechartered credit unions that are permitted under applicable state law to engage in derivatives transactions. It requires any credit union seeking derivatives authority to submit an application for one of two levels of authority. Level I and Level II authority differ on the permissible levels of transactions as well as the application, expertise, and systems requirements associated with operating a derivatives program. DATES: Comments must be received on or before July 29, 2013. ADDRESSES: You may submit comments by any of the following methods (Please send comments by one method only): • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • NCUA Web Site: http:// www.ncua.gov/ RegulationsOpinionsLaws/ proposed_regs/proposed_regs.html. Follow the instructions for submitting comments. • E-Mail: Address to regcomments@ncua.gov. Include ‘‘[Your name]—Comments on Proposed Rule— Derivatives’’ in the email subject line. • Fax: (703) 518–6319. Use the subject line described above for email. • Mail: Address to Mary Rupp, Secretary of the Board, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314– 3428. • Hand Delivery/Courier: Same as mail address. FOR FURTHER INFORMATION CONTACT: Justin M. Anderson or Lisa Henderson, Staff Attorneys, Office of General Counsel, at the above address or telephone (703) 518–6540; J. Owen Cole, Director, Division of Capital and Credit Markets, or Rick Mayfield, Senior Capital Markets Specialist, Office of Examination and Insurance, at the above address or telephone (703) 518–6360; or Dr. John Worth, Chief Economist, Office SUMMARY: PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 32191 of the Chief Economist, at the above address or telephone (703) 518–6660. SUPPLEMENTARY INFORMATION: I. Background A. Introduction The NCUA Board (Board) is proposing to allow credit unions to engage in limited derivatives transactions 1 for the purpose of mitigating interest rate risk (IRR). This proposed authority does not, however, allow credit unions to offer derivatives. This proposed rule applies to all federal credit unions (FCUs) and all federally insured state- chartered credit unions (FISCUs) that are expressly permitted by applicable state law to engage in derivatives transactions. The Board believes this proposed rule allows eligible credit unions to utilize an additional tool to mitigate IRR, while also reducing risk to the National Credit Union Share Insurance Fund (NCUSIF). The rule requires eligible credit unions to apply to NCUA or, in the case of a FISCU, NCUA and the applicable state supervisory authority (SSA), for either Level I or Level II derivatives authority. As discussed in greater detail below, Level I and Level II authority differ on the permissible levels of transactions as well as the application, expertise, and systems requirements. B. The Act and NCUA’s Regulations The Federal Credit Union Act (Act) provides FCUs with the authority to invest in certain securities, obligations, and accounts.2 For safety and soundness reasons, however, NCUA has adopted regulatory restrictions on certain investments and activities permitted by the Act.3 Currently, derivatives are among the investments specifically prohibited by NCUA.4 1 A derivative is an instrument whose price is dependent on or derived from one or more underlying assets. A derivatives transaction involves a contract between two parties, called counterparties, that exchange value based on the fluctuation of the underlying asset or index. A counterparty is the other party to the derivatives transaction and can include swap dealers and major swap participants, which are terms to identify entities that operate primarily in the derivatives market. These transactions may involve collateral and a collateral custodian, which is an entity that holds the collateral for the two contracting parties. 2 12 U.S.C. 1757(7) and (15). 3 12 CFR 703.16. 4 Id. at 703.16(a). Section 703.16(a), however, provides three exceptions to the general prohibition on derivatives. First, an FCU may purchase or sell any derivatives permitted under § 703.14(g) or under § 701.21(i) of NCUA’s lending regulations. Second, an FCU may purchase or sell an embedded option not required under generally accepted accounting principles (GAAP) to be accounted for separately from the host contract. Third, an FCU may enter into interest rate lock commitments or E:\FR\FM\29MYP1.SGM Continued 29MYP1

Agencies

[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Proposed Rules]
[Pages 32184-32191]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12763]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR part 417

[Docket No. FSIS-2009-0019]


HACCP Systems Validation

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of public meeting and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of updated guidance for Hazard Analysis Critical 
Control Point (HACCP) systems validation. In addition, FSIS is 
announcing that it will hold a public meeting on June 25, 2013, to 
review changes to the guidance announced in this notice and to take 
comments. The public meeting will also be available by teleconference.
    Following the public meeting, the Agency will accept written 
comments until July 25, 2013. Given the extensive opportunity for 
comment on the guidance, however, the Agency believes

[[Page 32185]]

that very few, if any, issues remain in this proceeding.

DATES: The public meeting will be held on June 25, 2013 from 8:30 a.m. 
to 12:30 p.m. On-site registration will begin at 8:00 a.m. Written 
comments may be submitted until July 25, 2013.

ADDRESSES: The public meeting will be held in the 1st Floor Auditorium 
of Patriots Plaza 3, 355 E Street SW., Washington, DC 20024.
    FSIS will finalize the agenda by June 18, 2013 and post it on the 
FSIS Web page at: http://www.fsis.usda.gov/News_&_Events/meetings_&_events/index.asp.
    Registration: Pre-registration is recommended. To pre-register, 
access the FSIS Web site at http://www.fsis.usda.gov/News_&_Events/meetings_&_events/index.asp. Call-in information will be provided via 
email to pre-registered participants. If you are interested in making a 
public comment during the teleconference, please indicate so on the 
registration form.
    In addition to the public meeting, interested persons may submit 
comments using either of the following methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture (USDA), FSIS, OPPD, RIMS, Patriots Plaza 3, 
1400 Independence Avenue SW., Mail Stop 3782, Room 8-163A, Washington, 
DC 20250-3700.
     Hand- or Courier-Delivered Submittals: Deliver to Patriots 
Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20024.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2009-0019. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at the address listed above between 8:30 a.m. 
and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: William K. Shaw, Jr., Ph.D., Office of 
Policy and Program Development, FSIS, USDA, 1400 Independence Avenue 
SW., Patriots Plaza 3, Mailstop 3782, Room 8-142, Washington, DC 20250. 
Telephone: (301) 504-0852 Fax: (202)245-4792. E-Mail: 
william.shaw@fsis.usda.gov.

Background

    FSIS administers the Federal Meat Inspection Act (FMIA) (21 U.S.C. 
601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 
451 et seq.) to protect the health and welfare of consumers by 
preventing the distribution in commerce of meat or poultry products 
that are unwholesome, adulterated, or misbranded. To reduce the risk of 
foodborne illness from meat or poultry products, FSIS issued 
regulations on July 25, 1996, which require that federally inspected 
establishments adopt HACCP systems (61 FR 38806). These regulations 
require that federally inspected establishments adopt measures to 
prevent or control the occurrence of food safety hazards at each stage 
of the production process where such hazards are reasonably likely to 
occur.
    In the May 9, 2012 Federal Register (77 FR 27135), FSIS issued a 
notice to clarify its requirements for validation by an establishment 
of its HACCP system and to announce the availability of the draft 
guidance on validation, which is discussed in more detail below. The 
HACCP regulations in 9 CFR part 417 require that establishments 
validate the HACCP plan's adequacy to control the food safety hazards 
identified by the hazard analysis (9 CFR 417.4(a)). These regulations 
prescribe requirements for the initial validation of an establishment's 
HACCP plan and require establishments to ``conduct activities designed 
to determine that the HACCP plan is functioning as intended.'' During 
this initial validation period, establishments are to ``repeatedly test 
the adequacy of the CCPs, critical limits, monitoring and recordkeeping 
procedures, and corrective actions'' prescribed in their HACCP plans (9 
CFR 417.4(a)(1)). As FSIS explained in the May 9, 2012 Federal 
Register, validation under 9 CFR 417.4(a)(1) requires that 
establishments assemble two types of data: 1) the scientific or 
technical support for the judgments made in designing the HACCP system, 
and 2) evidence derived from the HACCP plan in operation to demonstrate 
that the establishment is able to implement the critical operational 
parameters necessary to achieve the results documented in the 
scientific or technical support.
    The regulations also provide that ``[v]alidation . . . encompasses 
reviews of the records themselves, routinely generated by the HACCP 
system, in the context of other validation activities'' (9 CFR 
417.4(a)(1)). As FSIS explained in the May 9, 2012 Federal Register, if 
an establishment's supporting documentation for its hazard analysis 
includes records associated with a prerequisite program that provides 
for an intervention or process designed to prevent a hazard from being 
likely to occur, the establishment's validation records would need to 
include all documents associated with the prerequisite program. Thus, 
validation of the HACCP system involves validation of the critical 
control points in the HACCP plan, as well as of any interventions or 
processes used to support decisions in the hazard analysis.

Initial Draft Guidance

    In March 2010, FSIS posted on its Web site an initial draft 
guidance document to assist the industry, particularly small and very 
small establishments, in complying with the requirements for HACCP 
systems, pursuant to 9 CFR 417.4.
    On June 14, 2010, FSIS held a public meeting to discuss the initial 
draft HACCP validation guidance and received input from stakeholders. 
The transcript of the June 2010 public meeting is available on the FSIS 
Web site at: http://www.fsis.usda.gov/PDF/Transcripts_HACCP_Validation_061410.pdf.
    FSIS received over 2,000 comments on the initial draft guidance, 
particularly with respect to the use of microbiological testing to 
validate the effectiveness of HACCP systems in controlling biological 
hazards. The Agency considered the issues raised by the comments 
received in response to the May 2010 Federal Register notice and at the 
June 2010 public meeting and developed updated second draft compliance 
guidance.
    On September 22-23, 2011, FSIS shared a second draft of the HACCP 
validation guidance with the National Advisory Committee on Meat and 
Poultry Inspection (NACMPI). The Committee reviewed the draft and 
provided comments and suggestions to FSIS on how to improve the 
guidance. The NACMPI report is available on the FSIS Web site at: 
http://www.fsis.usda.gov/PDF/Validation_Issue_Paper_Final.pdf. The 
Agency made additional revisions to the draft guidance in response to 
the input from NACMPI.
    In a May 9, 2012 Federal Register notice, FSIS announced the 
availability of, and requested comments on, the revised draft guidance 
document

[[Page 32186]]

(http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2009-0019.htm). In the May 
2012 Federal Register notice, the Agency also clarified its 
requirements for HACCP system validation and responded to the comments 
that it had received on the initial draft guidance. The May 2012 
Federal Register notice explained that the Agency was soliciting 
comments on the revised draft, and that it would hold another public 
meeting before issuing final guidance for HACCP systems validation (77 
FR 27135).

Comments on the Guidance

    FSIS received fifty-one (51) comments on its May 2012 revised draft 
guidance on HACCP validation from small and very small meat or poultry 
processors, trade associations representing animal producers, small 
business owners, corporations, State Departments of Agriculture, and 
consumer advocacy organizations. FSIS has carefully considered the 
comments and has revised its draft guidance in light of these comments. 
The following is a brief summary and discussion of the major issues 
raised in the comments to the draft guidance document.

1. Concerns About Validation, Its Applicability, and Cost

    Comment: Several commenters asked why the validation guidance or 
new FSIS enforcement of validation requirements is necessary, 
especially given the amount of time the HACCP regulations have been in 
place. These commenters stated that establishments should not have to 
``revalidate'' their systems.
    Response: The validation guidance is necessary because the Agency 
found that establishments have not adequately validated their systems. 
During the process of developing the draft guidance, FSIS added an 
appendix to the document that explains the need for validation and 
FSIS's experiences that led it to create the guidance document (e.g., 
FSIS's findings following a 2011 Lebanon bologna outbreak that the 
establishment's scientific support on file did not match the process 
the establishment was using to make the bologna; non-O157 positives in 
2012 that FSIS concluded likely occurred because of improperly designed 
interventions; and the chicken pot pie outbreaks in 2007 that FSIS 
concluded may have occurred because of improperly validated cooking 
instructions).
    Based on findings from FSIS's data analyses and outbreak 
investigations, the Agency recommends that establishments use the 
guidance document to ensure that their HACCP systems are properly 
validated. On an annual basis, and whenever changes occur that affect 
the hazard analysis of the HACCP plan, the establishment should conduct 
a reassessment as required in 9 CFR 417.4(a)(3) (i.e., review records 
generated over the course of the previous year, or during the period 
the change occurred, that reflect how the HACCP system is performing as 
a whole and analyze them to determine whether food safety goals are 
being met).
    If the reassessment shows that the HACCP system is effective and 
functioning as intended, the establishment can consider continuing on 
with the same system and the same monitoring and verification 
procedures and frequencies. If reassessment shows that either their 
HACCP system was not set up correctly, is not being implemented 
consistently, or is no longer effective, the establishment would make 
changes to its HACCP system (e.g., add another intervention) and then 
would, in most cases, be required to validate any changes to its HACCP 
system.
    While most establishments have assembled the scientific or 
technical documentation needed to support their HACCP systems, many 
establishments have not gathered the necessary in-plant validation data 
demonstrating that their HACCP systems are functioning as intended, 
which is why the guidance document is necessary. As is explained below, 
in approximately six months from the time that FSIS issues the final 
validation guidance, FSIS intends to begin verifying that 
establishments comply with all validation requirements.
    Comment: Several commenters expressed concern about the cost of 
validation, particularly for small establishments that have many 
different HACCP plans. One comment stated that if a very small 
establishment cannot afford to comply with validation requirements, it 
should have the option to return to ``conventional'' inspection instead 
of HACCP. Commenters were also concerned about the costs of obtaining 
in-plant microbial data and other costs associated with validation.
    Response: HACCP was implemented in 1996 and has resulted in great 
improvements in food safety. The Agency is not going back to a command 
and control inspection approach because it would not provide 
establishments with the flexibility to design innovative systems that 
ensure food safety.
    In the guidance, FSIS states that microbiological testing is needed 
for in-plant data in only limited circumstances and has provided low 
cost ways in which establishments can validate their systems in place 
of microbiological testing, such as ensuring that they are meeting the 
critical operating parameters of the interventions as defined in the 
scientific support. Therefore, FSIS estimates that costs associated 
with meeting validation requirements will be minimal.
    Comment: Several commenters stated that establishments should not 
have to validate their prerequisite programs because 9 CFR 417.4(a)(1) 
does not apply to prerequisite programs. One commenter recommended 
that, in the absence of a CCP, prerequisite programs referenced in the 
flow chart should be validated, but that otherwise, establishments 
should not be required to validate their prerequisite programs. The 
same commenter also requested that FSIS begin only reviewing validation 
for CCPs and then, at a later date, begin reviewing validation for 
prerequisite programs referenced in the flow chart. One commenter 
stated that only prerequisite programs that contain scientifically 
supported critical operating parameters (e.g., foreign material 
control, Good Manufacturing Practices, employee hygiene) should have to 
be validated. Several commenters stated that they needed guidance 
concerning how to validate pest control, employee hygiene, sanitation 
practices, and other processes.
    Response: Validation is the process of demonstrating that the HACCP 
system, as designed, can adequately control identified hazards to 
produce a safe, unadulterated product. Prerequisite programs designed 
to support a decision in the hazard analysis are part of the HACCP 
system. When an establishment determines that a hazard is not 
reasonably likely to occur because the prerequisite program prevents 
the hazard, that prerequisite program becomes part of the HACCP system. 
Therefore, prerequisite programs designed to support decisions in the 
hazard analysis (e.g. Sanitation Standard Operating Procedures 
(Sanitation SOPs), purchase specifications, antimicrobial 
interventions) need to be validated to ensure that the overall system 
can operate effectively. Even though 9 CFR 417.4(a)(1) does not refer 
to Sanitation SOPs or other prerequisite programs, establishments' 
initial validation activities need to include employee hygiene and 
other similar prerequisite programs if they are used to support 
decisions in the hazard analysis. As explained in the guidance, in 
order to validate such programs, establishments

[[Page 32187]]

need to provide scientific documentation that supports that they will 
work as intended and to collect in-plant data to support that the 
programs can be implemented as designed.
    Comment: Some commenters stated that establishments should not be 
required to validate cooking instructions because the cooking is 
performed by the consumer. One comment stated that discussion of 
validating the time and temperature combinations for cooking 
instructions should be removed from the guidance. Another commenter 
requested more guidance on how establishments should validate cooking 
instructions. Another commenter asked for confirmation that validated 
cooking instructions are not considered a CCP.
    Response: An establishment must validate all measures that it 
relies upon to prevent or control the hazards that it has identified in 
its HACCP system, whether the measures are part of the HACCP plan 
itself or part of a program that includes measures that affect the 
hazard analysis. Thus, if an establishment's HACCP system includes 
cooking instructions as a measure to address a potential food safety 
hazard after entry into the establishment, the establishment must 
properly validate the instructions.
    As we saw in the 2007 salmonellosis outbreak associated with 
chicken pot pies, providing cooking instructions on a package that 
cannot be repeated by the consumer represents an increased risk to the 
consumer. Had the establishment validated the cooking instructions on 
the pot pies to ensure they would achieve the desired endpoint 
temperature under actual consumer cooking conditions, these illnesses 
may have been prevented (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5747a3.htm).
    If an establishment's HACCP system includes placing cooking 
instructions on the product's label, the instructions must be validated 
to ensure that consumers who follow the instructions will achieve the 
endpoint time/temperature needed to ensure that the product is cooked 
and safe to consume. While validated cooking instructions may be used 
as a control to address hazards that may occur after the product has 
left the establishment, the establishment is still required to address 
food safety hazards that are reasonably likely to occur in the 
production process and identify the measures the establishment can 
apply to control those hazards (9 CFR 417.2(a)(1). http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5747a3.htm).
    FSIS is in the process of developing a guidance document on 
validating cooking instructions for mechanically tenderized beef 
product. FSIS has previously recommended validated cooking instructions 
for product that appears to be ready-to-eat, but its meat or poultry 
components have not received a sufficient lethality step or some other 
component has not received a lethality step. http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/10240.4/Resource_1.pdf Resource 1 for NRTE 
products that appear to be RTE (e.g., entrees, dinners, casseroles etc) 
http://www.fsis.usda.gov/PDF/Info_on_Validation_of_Labeled_Cooking_Instructions_Raw_or_Partially_Cooked_Poultry.pdf 
(validated cooking instructions) http://www.fsis.usda.gov/PDF/Labeling_Policy_Guidance_Uncooked_Breaded_Boneless_Poultry_Products.pdf (this link includes the background information and Q&As)
    Comment: Several comments stated that establishments should not be 
required to collect in-plant data for more than one product in a HACCP 
process category. These commenters also requested guidance on how to 
select a product from within each HACCP category. Commenters noted that 
such in-plant data would include execution data for all CCPs, 
interventions, and prerequisite programs used to support decisions in 
the hazard analysis. One commenter questioned whether the establishment 
would need to validate the food safety system for each product if the 
only difference among products is a seasoning. Another commenter stated 
that it is possible to have in-plant data for product of one species 
within a HACCP category serve as in-plant data to validate the process 
for product from another species if there are no additional food safety 
concerns. Another commenter stated that FSIS's guidance should follow 
the NACMPI recommendations to group typical products into categories 
and select ``worst case products'' within the group.
    Response: In the revised guidance, FSIS has clarified that 
establishments are not required to collect in-plant data for more than 
one product within a HACCP process category. The guidance now provides 
information concerning how establishments should select a product from 
within a HACCP category. The guidance also provides information on how 
establishments can develop a decision-making document concerning 
product choices for collecting in-plant data. The guidance provides 
examples of how to collect in-plant data to aid industry, but 
establishments will have the flexibility to develop their own criteria.
    Comment: A few commenters requested confirmation that 
establishments would not have to conduct ``initial'' validation for all 
changes that result from reassessment. Several commenters asked whether 
the whole system would need to be validated or just a change following 
reassessment. One commenter stated that improved implementation of a 
HACCP system would not necessarily result in changes to the design of 
the system.
    Response: Establishments do not need to conduct validation of the 
whole system for all changes that result from reassessment. Depending 
on the change, the establishment will likely only need to validate that 
the change is functioning as intended. For example, an establishment 
may change the thickness of a raw patty product and determine that it 
only needs to validate that the cooking instructions still achieve the 
desired endpoint temperature at the new product thickness. In this 
example, the establishment would not need to validate the entire HACCP 
system.
    Comment: Several commenters stated that very small establishments 
that produce products infrequently cannot obtain 13 production days 
worth of records within 90 calendar days. One commenter suggested 
extending the validation period beyond 90 calendar days in order to 
obtain 13 days worth of records. Another commenter requested that the 
guidance document clarify that large establishments have the 
flexibility to determine whether there are a sufficient number of 
production days within the 90 calendar-day period to gather appropriate 
data.
    Response: The guidance explains that for large establishments, 90 
calendar days equates to approximately 60 production days. FSIS 
recognizes that many small and very small establishments do not operate 
daily. Therefore, the guidance also states that 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. The establishment should consider 
focusing validation activities on the product produced most frequently 
within each HACCP category.
    In the guidance, FSIS recognizes that there are some establishments 
that produce products so infrequently that they would not be able to 
gather records from 13 production days within those 90 initial calendar 
days. If the establishment infrequently produces several products that 
are each part of a separate HACCP category, there is

[[Page 32188]]

inherent risk with the processes if the establishment does not have 
experience in producing them. Therefore, to determine whether the 
system is properly designed and executed, even though the regulations 
provide 90 days for a conditional grant of inspection (9 CFR 304.3(b)), 
an establishment needing more than 90 days can ask the District Office, 
in writing, for additional time to collect at least 13 production days 
of records. The guidance explains that establishments may also consider 
evaluating data collected for products across multiple HACCP categories 
that share some common steps, ingredients, or equipment, to determine 
whether the data together can support its ability to meet critical 
operational parameters.
Scientific Support
    Comment: Appendix A of the final rule, ``Performance Standards for 
the Production of Certain Meat and Poultry Products'' (64 FR 746-748) 
is specific to Salmonella but is often used to support lethality of 
other pathogens, such as E. coli O157:H7 and Lm. Therefore, several 
commenters asked whether establishments could use Appendix A as 
scientific support for process controls for pathogens other than 
Salmonella.
    Response: FSIS has revised the validation guidance to clarify that 
during slaughter, in order to be most effective, it is very important 
that interventions have been studied for the pathogen and product pair 
of interest. In addition, FSIS has clarified that for thermal 
processing treatments, Salmonella can be used as an indicator for other 
pathogens of concern. Therefore, Appendix A can be used as scientific 
justification for the process without further support that the results 
apply to other pathogens such as E. coli O157:H7 or Lm.
    Comment: Some commenters questioned whether their scientific 
support must be peer-reviewed. One commenter asked whether a processing 
authority could be an establishment owner with knowledge of the 
process. The commenter also asked if it could use documents that only 
provide a critical limit as scientific support (for example, a 
University publication or a textbook with growth limits of bacteria).
    Response: FSIS has revised the guidance to clarify that the Agency 
recommends peer-reviewed scientific data to support the process used, 
but does not require peer-reviewed data. An establishment may use peer-
reviewed scientific data or information in addition to a scientific 
article from a peer-reviewed journal as scientific support for its 
processes. Such information would include data from a textbook on the 
growth limits of certain pathogens, based on a food product's water 
activity and pH. This information could be used as scientific support 
because information in scientific textbooks has generally been peer-
reviewed. Peer-reviewed scientific data goes through a process of 
evaluation involving qualified individuals within the relevant field 
that ensures the integrity of the data.
    Scientific data that is not peer-reviewed is less reliable than 
peer-reviewed data, because there could be flaws in the science that a 
peer review would have revealed. If an establishment uses scientific 
data that is not peer-reviewed, the establishment may be subject to 
additional scrutiny by Agency personnel performing verification 
activities.
    An establishment may rely on a process authority to provide 
necessary scientific support for the establishment's process. As stated 
above, to meet validation requirements, the establishment is required 
to ensure that the scientific data and documentation provided by the 
processing authority supports that the process addresses the identified 
hazards, and meets the expectations for validation requirements.
    Comment: Several commenters stated that the guidance document is 
still too vague in terms of how close the scientific support needs to 
match an actual process. For example, commenters asked whether the 
manufacturer of a grinder would have to be the same as the grinder used 
in a supporting study. Commenters also asked how significant casing 
size differences among the process used and support studies would need 
to be before the support document would no longer apply. Commenters 
stated that parameters are often more controlled during research than 
in-plant, and that it is costly for establishments to measure 
temperature and pounds per square inch.
    Response: In the guidance, FSIS has clarified how scientific 
support should match an actual process. Generally, establishments 
should use the same critical operational parameters as those in the 
support documents. In some circumstances, establishments may be able to 
support using critical operational parameters that are different from 
those in the support documents (e.g., higher concentrations of 
antimicrobials or higher thermal processing temperatures). 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. Similarly, 
higher processing temperatures may result in the surface of the product 
drying out before adequate lethality is achieved. Establishments also 
need to ensure the levels are safe and suitable (http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/7120.1.pdf and 9 CFR 
424.21(c)).
    Comment: Several commenters stated that FSIS Notice 36-12 (http://www.fsis.usda.gov/oppde/rdad/FSISNotices/36-12.pdf) suggested that the 
challenge study establishments used in the case of the Lebanon bologna 
would not be adequate support because the critical operational 
parameters in the study did not match those used in the establishment.
    Response: The FSIS notice on Lebanon bologna explained that the 
actual process that the establishment used did not match the scientific 
support. As a result, the establishment's process did not achieve 
adequate lethality. Establishments producing Lebanon bologna can use 
the guidance as scientific support; however, they need to ensure that 
their process meets the critical operating parameters used in the 
study.
    FSIS recognizes that scientific support performed in a laboratory 
may not always match an establishment's exact parameters. However, 
significant differences, such as the permeability of the casing used or 
the diameter of the product, are key factors that affect lethality and 
therefore cannot be overlooked. For instance, if an establishment wants 
to use a permeable casing, the establishment cannot assume that its 
process will achieve the same reduction in pathogens as achieved in a 
study using an impermeable casing.
    Comment: Some comments stated that discussion of critical 
operational parameters in the guidance will lead some to conclude that 
all parameters are critical. Several commenters requested that FSIS 
create a third party or consortium to help establishments identify 
scientific support and critical operational parameters. Another 
commenter requested that FSIS's guidance address validation and 
scientific support for additional hazards, such as viruses and 
protozoa.
    Several commenters stated that establishments do not have the 
expertise to scientifically support or identify critical operational 
parameters. One commenter stated that establishments

[[Page 32189]]

do not know how to test parameters of the different processes.
    Response: Critical operational parameters are the specific 
conditions that the intervention must operate under in order for it to 
be effective. The guidance document explains in detail how an 
establishment can identify the critical operational parameters in its 
scientific support. Specifically, Appendix 3, provides step-by-step 
guidance to establishments.
    FSIS will continue to post commonly cited journal articles on its 
Web site in which critical operational parameters have been identified 
and will offer support through askFSIS to establishments trying to 
identify critical operational parameters.
    Comment: One commenter requested that reference to Purac's modeling 
program be made within the guidance, and that the guidance address the 
use of pathogen modeling programs as scientific supporting 
documentation. The commenter also requested an additional example in 
the guidance to show how an establishment could validate the 
effectiveness of an antimicrobial agent through pathogen modeling.
    Response: FSIS has added a reference to pathogen modeling as a type 
of scientific support. In addition, FSIS has added an example in 
Appendix 3 to show how an establishment can validate its stabilization 
process through pathogen modeling. FSIS does not advocate certain 
programs and therefore did not cite Purac in the guidance.
    Comment: One commenter requested a listing of surrogate or 
indicator organisms that can be used for validation. Another commenter 
requested clarification on when establishments can use scientific 
support based on indicator organisms.
    Response: As explained in the guidance document, establishments 
should not rely on scientific support containing data from indicator or 
surrogate organisms unless available data establishes a relationship 
between the presence or level of a pathogen or toxin and the indicator 
organism. Such data can be collected from in-laboratory studies using 
indicator organisms that parallel the data in a challenge study 
performed with the inoculated pathogen. This data could be collected in 
the same way in which the pathogen is being tested or in another study 
performed under similar conditions. If similar and consistent reduction 
or control can be established, then control of the indicator organisms 
can be reliably used to indicate expected pathogen control in actual 
application in-plant.

2. Validation Worksheet Examples

    Comment: One commenter stated that FSIS should include an 
explanation of how the validation worksheet examples can be used. 
Another commenter recommended that the guidance state that 
establishments have flexibility to utilize approaches other than those 
in the worksheet examples. Two commenters recommended that FSIS 
recognize in the guidance that not all critical operational parameters 
identified in the Appendix will apply to all processes.
    Another commenter requested more detail be provided in the 
worksheet examples in terms of formatting and the types of data that 
establishments should collect.
    One comment stated that establishments' environmental monitoring 
verifies that the Sanitation SOPs are working as intended, but does not 
validate them.
    Response: In the guidance document, FSIS has added numerous 
validation worksheet examples to illustrate how an establishment may 
want to display its own in-plant validation data. As FSIS explains in 
the guidance, the validation worksheet examples are for illustration 
purposes only and are included to help establishments to understand the 
types of scientific support and in-plant documentation that are needed 
to comply with the validation requirements.
    With regard to the comment on the Sanitation SOP monitoring, FSIS 
included this data in the guidance as an example of data collected 
during the initial 90 days of the set-up of a new program. Scientific 
support is needed to support the frequency of testing (which would 
address the factors used to determine the frequency). In-plant 
validation data is needed to support that the testing is adequate.

3. Microbiological Testing

    Comment: One comment asked for clarification as to whether samples 
need to be collected for each and every process, product, or species, 
and whether establishments would need to collect 13 samples for every 
product produced, as in the regulations that require establishments to 
conduct testing for generic E. coli (9 CFR 310.25 and 381.94)
    Response: If an establishment's scientific support contains 
microbiological data showing the efficacy of the intervention against 
the identified food safety hazard, then the in-plant data does not need 
to include sampling. In that case, the in-plant data should support 
that the establishment follows the critical operational parameters from 
the study.
Agency Training and Implementation
    Comment: Commenters stated that FSIS should ensure that inspection 
program personnel consistently verify and enforce validation 
requirements. One commenter stated that FSIS should share training for 
FSIS personnel with industry.
    A commenter also recommended that FSIS hold regional sessions to 
communicate the policy to establishments, and that the Agency engage 
cooperative extension programs in its communication strategy. One 
commenter recommended that the Agency create a tutorial on 
understanding scientific articles and on identifying critical 
operational parameters. Commenters also requested that FSIS issue a 
notice or directive explaining how inspectors should use the validation 
guideline.
    A few commenters requested that FSIS phase-in verification of 
validation requirements based on risk or product categories, rather 
than establishment size. One commenter requested an additional six 
months to gather validation documents before FSIS begins new 
verification activities related to validation.
    Response: The guidance is meant for establishments. FSIS will 
ensure inspection program personnel understand validation requirements 
and will issue necessary instructions to field personnel so that they 
are aware of the final guidance and share it with establishments. FSIS 
will also issue necessary instructions to field personnel for them to 
verify that establishments meet all validation requirements.
    FSIS will implement its new verification activities by phasing them 
in based on establishment size. For large establishments, the agency 
plans to wait approximately six months from the date that the final 
guidance is issued to start verifying and enforcing the second element 
of validation (initial in-plant validation). Thus, large establishments 
will have six months from the date that the final guidance is issued to 
gather all necessary in-plant demonstration documents.
    FSIS intends to begin verifying that small and very small 
establishments meet all validation requirements nine months from the 
date the final guidance is issued. Therefore, these establishments will 
have approximately nine months from the date the final guidance is 
issued to gather all necessary in-plant demonstration documents before 
FSIS will verify and

[[Page 32190]]

enforce the second element of validation.

Other Changes to Validation Guidance

    Examples: The guidance contains additional examples of food safety 
problems linked to inadequate validation and recommendations to aid 
establishments in meeting initial validation requirements. These 
examples demonstrate the need for validation and provide support for 
recommendations made within the guidance.
    Scientific Support Documents. FSIS has added a section to the 
guidance that explains to establishments how to determine whether 
scientific support documents are sufficiently related to the process, 
product, and hazard identified in the hazard analysis to constitute 
appropriate validation. The guidance explains that the supporting 
documentation should identify the hazard (biological, physical, and 
chemical), the expected level of hazard reduction or prevention to be 
achieved, all critical operational parameters or conditions necessary 
to address the hazard, the processing steps that will achieve the 
specified reduction or prevention, and how these processing steps can 
be monitored. FSIS has also included information on how establishments 
can identify supporting documentation that adequately addresses the 
expected level of hazard or reduction or prevention to be achieved. 
FSIS provided examples for biological, physical, and chemical hazards 
that should aid establishments in ensuring that the scientific support 
closely matches the hazard being controlled. FSIS has also clarified 
when establishments may use scientific support containing data from 
indicator or surrogate organisms.
    Critical Operational Parameters. The guidance continues to state 
that critical operational parameters are those necessary for 
interventions to be effective and explains how an establishment can 
identify the critical operational parameters in its scientific support. 
As discussed above in response to comments, establishments generally 
should use the same critical operational parameters as those in the 
support documents. However, in some circumstances, establishments may 
be able to support using critical operational parameters that are 
different from those in the support documents (e.g., higher 
concentrations of antimicrobials or higher thermal processing 
temperatures). In these cases, establishments should provide 
justification supporting that the levels chosen are at least as 
effective as those in the support documents.
    FSIS has added an additional Appendix (Appendix 2) to provide an 
example of a decision-making document an establishment could develop 
when it uses different levels of a critical operational parameter than 
the parameters in the support document. An establishment may use the 
decision-making document to explain the scientific rationale for why it 
is using critical operational parameters that are different from those 
in the support documents.
    In-plant data. The guidance recommends that establishments collect 
in-plant validation data for a wide variety of products and worst case 
scenarios. Appendix 4 of the guidance contains validation worksheet 
examples that establishments may reference to help them understand the 
types of scientific support and in-plant documentation that are needed 
to comply with the validation requirements.
    Initial validation vs. on-going verification. The guidance explains 
the differences between initial validation and on-going verification 
and the relationship between the activities performed to provide 
initial validation as opposed to on-going verification. The revised 
guidance also clarifies when changes that result from reassessment 
would not require validation. For example, an establishment may need to 
reassess its HACCP system following a change in supplier of a raw 
material, but the change would not require validation if the 
establishment determines that the composition of the raw material and 
microbiological profile are not significantly different from the 
material provided by the previous supplier. In other cases, changes 
that result from the reassessment would not require additional 
scientific support but would require additional in-plant demonstration 
data. For example, an establishment may find through reassessment that 
the design of an intervention was adequate, but that its employees are 
not implementing the intervention correctly. In that case, the 
establishment would only need to collect in-plant data to demonstrate 
that the intervention could be implemented appropriately. Depending on 
the change, the establishment would likely only need to validate that 
the change is functioning as intended and not the entire HACCP system. 
The current draft of the compliance guide is available for public 
viewing in the FSIS docket room and on the FSIS Web site at http://www.fsis.usda.gov/Significant_Guidance/index.asp.

Public Meeting

    On June 25, 2013, the Agency will hold a public meeting to review 
the information presented in this document and accept comments.

Next Steps

    Following the public meeting, the Agency will accept public comment 
for 30 days. Given the extensive opportunity for public comment on the 
compliance guide, it is likely that there are very few, if any, 
remaining issues. Therefore, FSIS does not foresee granting an 
extension to this final 30 day comment period. As soon as possible 
after the comment period ends, the Agency will issue a Federal Register 
notice announcing the final guidance and will post the final guidance 
to its Web page. FSIS will implement its new verification activities 
phased in by establishment size. As stated above, for large 
establishments, the Agency plans to delay verification of the second 
element of validation as part of its inspection activities for 
approximately six months from the date the final guidance is posted. 
For small and very small establishments, the Agency plans to delay 
implementation for approximately nine months from the date the final 
guidance is posted.
    Until FSIS begins enforcing all validation requirements, FSIS 
inspection personnel will continue to issue noncompliance records (NRs) 
if an establishment lacks the required scientific or technical support 
for its HACCP system, or if the scientific or technical support is 
inadequate. FSIS will continue to issue a Notice of Intended 
Enforcement if, taken together with other relevant findings, an 
establishment's scientific or technical support is inadequate, and the 
Agency can support a determination that the establishment's HACCP 
system is inadequate for any of the reasons provided in 9 CFR 417.6.
    Moreover, if, in conducting a Food Safety Assessment (FSA), an 
Enforcement, Investigations, and Analysis Officer (EIAO) finds that an 
establishment has not collected in-plant data to demonstrate that its 
HACCP process works as intended, the EIAO will note this finding in the 
FSA and inform the establishment. Until FSIS begins enforcing the in-
plant data requirements, FSIS will not issue NRs or take enforcement 
actions based solely on a finding that an establishment lacks in-plant 
validation data.

Additional Public Notification

    FSIS will announce this notice online through the FSIS Web page 
located at

[[Page 32191]]

http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
    FSIS will also make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. In addition, FSIS offers an electronic mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range 
from recalls to export information to regulations, directives and 
notices. Customers can add or delete subscriptions themselves, and have 
the option to password protect their accounts.

USDA Nondiscrimination Statement

    USDA prohibits discrimination in all its programs and activities on 
the basis of race, color, national origin, gender, religion, age, 
disability, political beliefs, sexual orientation, and marital or 
family status. (Not all prohibited bases apply to all programs.) 
Persons with disabilities who require alternative means for 
communication of program information (Braille, large print, or 
audiotape.) should contact USDA's Target Center at (202) 720-2600 
(voice and TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call (202) 720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

    Done at Washington, DC on May 23, 2013.
Alfred V. Almanza,
Administrator.
[FR Doc. 2013-12763 Filed 5-24-13; 8:45 am]
BILLING CODE 3410-DM-P