Modernization of Poultry Slaughter Inspection, 24873-24878 [2012-10111]

Download as PDF 24873 Proposed Rules Federal Register Vol. 77, No. 81 Thursday, April 26, 2012 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 381 and 500 [Docket No. FSIS–2011–0012] RIN 0583–AD32 Modernization of Poultry Slaughter Inspection Food Safety and Inspection Service, USDA. ACTION: Proposed rule; extension of comment period. AGENCY: The Food Safety and Inspection Service (FSIS) is extending the comment period for the proposed rulemaking ‘‘Modernization of Poultry Slaughter Inspection’’ and responding to questions and addressing issues that have been raised concerning the proposed rule. The comment period was scheduled to close on April 26, 2012. During the comment period, a coalition of consumer advocacy organizations and two trade associations representing the poultry industry asked that FSIS clarify certain aspects of the proposed rule to help inform their comments. This document summarizes the issues raised by these groups and FSIS’s response. FSIS is also soliciting additional comments on how it should implement the final rule resulting from the proposal and requesting available data on any worker safety issues associated with increased line speeds. FSIS received a request to hold a public technical meeting on the proposed rule. FSIS does not believe that such a meeting would be useful. The Agency will, however, assess public understanding of the proposed rule in connection with its review and evaluation of the comments submitted and will respond as appropriate. DATES: The proposed rule published January 27, 2012 (77 FR 4408) is extended. Comments are due May 29, 2012. emcdonald on DSK29S0YB1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 15:15 Apr 25, 2012 Jkt 226001 Comments may be submitted by 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 https://www.regulations.gov. Follow the online instructions at that site for submitting comments. • Mail, including floppy disks or CD– ROMs, and hand- or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture (USDA), FSIS, Docket Clerk, Patriots Plaza 3, 355 E. Street SW., 8–163A, Mailstop 3782, Washington, DC 20250–3700. Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS– 2011–0012. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Assistant Administrator, Office of Policy and Program Development, FSIS, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250–3700, (202) 720– 2709. SUPPLEMENTARY INFORMATION: ADDRESSES: Background On January 27, 2012, FSIS published a proposed rule, ‘‘Modernization of Poultry Slaughter Inspection’’ (77 FR 4408). In that document, the Agency proposed a new inspection system for young chicken and turkey slaughter establishments that would replace all of the existing inspection systems except for traditional inspection. Key elements of the proposed new inspection system include: (1) Requiring that establishment personnel sort carcasses and remove unacceptable carcasses and parts before the birds are presented to the FSIS carcass inspector; (2) reducing the number of on-line carcass inspectors to one; (3) permitting faster line speeds than are permitted under the existing inspection systems; and (4) replacing the existing Finished Product Standards (FPS) with a requirement that establishments that operate under the new inspection system maintain records to document that the products resulting PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 from their slaughter operations meet the definition of ready-to-cook poultry. In addition to the proposed new inspection system, FSIS also proposed changes that would require, among other things, that all establishments that slaughter poultry other than ratites develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens and fecal material, and that they incorporate these procedures into their HACCP plan or sanitation standard operating procedures (SOP) or other prerequisite programs. During the comment period for the proposal, FSIS officials met with representatives from a coalition of consumer advocacy organizations and two trade associations representing the poultry industry. The consumer advocacy coalition and one of the trade associations had requested that FSIS clarify certain aspects of the proposed rule to inform their comments on the proposal. Because the issues addressed in these meetings may be relevant to the development of comments from other stakeholders, a brief summary of these issues and the Agency’s response are described below. The other trade association requested that FSIS provide additional information on how the Agency intends to implement the proposed new poultry inspection system. The groups submitted written questions to the Agency to consider before each meeting. The issues raised on implementation are summarized in a separate section of this document that outlines and requests comments on how the Agency plans to implement the final rule. Summary of Issues Raised and FSIS Response In addition to the questions outlined below, certain members of consumer advocacy organizations requested that FSIS hold a public technical meeting on the proposed rule. FSIS is clarifying certain aspects of the proposed rule in this Federal Register notice and will assess public understanding of the proposed rule in connection with its review and evaluation of the comments submitted. The Agency will provide any needed clarification if a final rule is adopted. Following is a summary of the issues raised and FSIS’s response. E:\FR\FM\26APP1.SGM 26APP1 24874 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Proposed Rules emcdonald on DSK29S0YB1PROD with PROPOSALS 1. Issues Raised by the Consumer Advocacy Coalition Comment: Why does FSIS believe that it is preferable for plant employees to sort carcasses? FSIS response: Under the existing inspection systems, on-line inspectors conduct activities that do not have a direct impact on public health. If the proposal is finalized, and the establishment conducts sorting activities, the only birds presented to the carcass inspector (CI) would be those that are likely to pass inspection. Therefore, the CI will be able to focus on food safety-related activities, such as verifying that carcasses affected by septicemia or toxemia or contaminated with visible fecal material do not enter the chiller. For these reasons, the Agency is proposing to remove certain on-line inspection activities that are not directly related to public health. Comment: Is there any guarantee that FSIS inspectors would be performing more food safety-related activities under the proposed new inspection system? FSIS response: Yes, generally inspectors would be performing more food safety-related activities. There are three important aspects of the proposed rule that would allow FSIS inspectors to conduct more food safety-related activities. First, because the on-line CI would not be responsible for sorting carcasses for quality-related defects, the amount of time that the CI spends focusing on food safety-related activities would increase. Second, under the proposed new inspection system, the offline verification inspector (VI) would primarily conduct food safety-related activities, such as verifying compliance with HACCP and sanitation SOP requirements and collecting product samples. Third, because FSIS considers contamination by enteric pathogens and fecal contamination to be hazards that are reasonably likely to occur, FSIS is proposing to require that all establishments that slaughter poultry have written programs to address sanitary dressing procedures, and that, at a minimum, these procedures include microbiological testing at pre-chill and post-chill to monitor process control. In addition to conducting verification checks on carcasses, FSIS off-line inspectors would be reviewing the establishment’s records and test results to verify that the establishment maintains process control. Comment: What type of training would FSIS require for establishment employees assigned to sort carcasses? FSIS response: The proposed rule does not prescribe training for establishment employees. However, as VerDate Mar<15>2010 15:15 Apr 25, 2012 Jkt 226001 noted in the preamble to the proposed rule, FSIS expects to convert the current instructions that it provides to Agency inspectors into guidance for industry to use to train plant sorters (77 FR 4419). Comment: What would establishment employees be required to do as part of their sorting activities? FSIS response: Should the rule become final, establishment sorters would be required to identify carcasses with septicemia/toxemia and other condemnable conditions and to remove them from the line before they reach the CI. Establishment employees would also need to conduct trimming and reprocessing before the birds reach the CI. Comment: Will establishment employees need to look inside the bird as part of their sorting responsibilities? FSIS response: Septicemic/toxemic birds exhibit signs on the outside of the carcass, so there is no need to look at the viscera. The regulations that prescribe conditions for condemnation in 9 CFR 381.81–381.93 would still apply. Establishment personnel would need to conduct sorting activities to address these condemnable conditions before the birds reach the CI. The conditions described in these regulations can be readily identified by examining the outside of the carcass. Lesions on the viscera do not require condemnation of the entire carcass except for lesions associated with visceral leukosis. The proposed rule provides for a 300-bird inspection of young chickens with the viscera (77 CFR 4421–4422). If the inspector finds signs or symptoms associated with visceral leukosis, then the entire flock would be inspected for the disease. All growers vaccinate birds for visceral leukosis. Therefore, it is seen only on rare occasions if the vaccine fails. Comment: How does the proposed rule address other consumer protection (OCP) issues, such as digestive tract contents found on products, that may affect internal parts of the carcass? FSIS response: There is a difference between fecal material and ingesta as digestive tract contents. We have no evidence to show that ingesta carries the same microbes as fecal contamination. Under the proposal, FSIS would enforce OCP processing defects that are associated with digestive tract contents, other than fecal contamination, in enforcing the ready-to-cook (RTC) poultry standard. Comment: Where would the establishment’s critical control point (CCP) for visible fecal contamination be located? FSIS response: FSIS does not prescribe where establishments must locate CCPs. The CI would be located PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 before the chiller. Visible fecal contamination would need to be removed before the carcass is presented to the CI. The VI would be conducting verification checks for fecal contamination off-line. If the VI detects fecal contamination offline, the plant has exceeded the zero tolerance for visible fecal contamination. The present inspection system is similar to the proposed system in that there are inspectors located upstream, and zero tolerance is enforced at a point at final wash, before the carcass enters the chiller. However, under the proposed new system the CI is more likely to observe visible fecal contamination because the carcasses would be free from animal diseases and trim and processing defects. Comment: Under the proposed rule, can FSIS take regulatory action throughout the entire dressing process? FSIS Response: The proposed rule would require that establishments develop, implement, and maintain procedures to address contamination by enteric pathogens and fecal material throughout the entire slaughter and dressing process. Through inspection activities, FSIS would ensure that the establishment’s procedures are effective, and the Agency would take appropriate regulatory action when necessary. Comment: Would there be an approval process for the establishment’s procedures to prevent contamination with enteric pathogens and fecal material? FSIS response: There would be no pre-approval of an establishment’s procedures. However, establishments would need to ensure that their procedures for preventing contamination are effective. To verify that an establishment’s procedures are effective, FSIS would consider: (1) The microbiological data that the establishment would be required to collect pre-chill and post-chill to demonstrate process control; (2) presence of visible fecal contamination; and (3) FSIS sampling results for Salmonella and Campylobacter. Comment: What was the basis for the baseline sampling numbers presented in the preamble to the proposed rule (74 FR 4442)? FSIS response: The estimates for sampling come from the economic analysis and reflect what we estimate to be the amount of sampling that plants would conduct if the proposed rule is adopted by the Agency. We are not proposing to prescribe how often establishments must test. Establishments would need to determine the frequency and type of sampling that would be sufficient to E:\FR\FM\26APP1.SGM 26APP1 emcdonald on DSK29S0YB1PROD with PROPOSALS Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Proposed Rules demonstrate that they are maintaining process control. Comment: Why is FSIS not mandating a frequency for testing? FSIS response: As stated in the preamble to the proposed rule, FSIS is proposing to require that an establishment’s sampling frequency be adequate to monitor the effectiveness of its process control for enteric pathogens (77 FR 4428). The frequency with which establishments would need to conduct such testing would depend on a number of factors, including their production volume, the source of their flocks, their slaughter and dressing process, and the consistency of their microbial test results over time. Because the testing frequency would be an integral part of an establishment’s HACCP system verification procedures, establishments would need to collect and maintain data to demonstrate that their testing frequency is adequate to verify the effectiveness of their process control procedures. Comment: Why did the Agency propose two points for microbiological testing instead of three? FSIS response: As noted in the preamble to the proposed rule, FSIS had considered requiring testing at three points in the process, i.e., re-hang, prechill and post-chill (77 FR 4428). The proposed rule provides for testing at pre-chill and post-chill because the Agency tentatively concluded that verification testing conducted at these two points would provide the evidence establishments need to verify that their process control measures are effective in preventing carcasses from becoming contaminated with pathogens. In the preamble to the proposed rule, the Agency explained that it considered requiring a third verification test at the re-hang position to monitor the incoming load of pathogens but tentatively decided that it was not necessary to impose the additional costs that would be associated with testing at this point (77 FR 4428). FSIS also considered requiring only one verification test at any position along the production line to provide maximum flexibility but concluded this approach may not be sufficient to monitor the effectiveness of an establishment’s procedures to prevent contamination throughout the slaughter and dressing operation. The Agency requests comments on these alternatives. Comment: Can CI inspectors stop or slow the line? FSIS response: If the CI observes a condemnable condition, either food safety or generalized OCP condition requiring condemnation of the entire VerDate Mar<15>2010 15:15 Apr 25, 2012 Jkt 226001 carcass, the CI would be authorized to stop the line to prevent such carcasses from entering the chiller. The CI would communicate the findings to the VI and inspector-in-charge (IIC). The IIC would consider available data to reset the line speed. Line speed would be determined by IIC’s assessment of the frequency of carcass defects identified by the CI and the VI and the plant’s control of its processes. Comment: Would offline inspectors be available to visually inspect carcasses under the proposed new system. FSIS response: The off-line VI would be checking carcasses to verify that they do not contain food safety-related contamination or defects. Comment: How many HACCP verification activities would occur under the new system versus the old system? FSIS Response: HACCP and sanitation verification activities would be a higher fraction of inspection activities under the proposed new inspection system as the Agency reduces its focus on quality and other OCP defects. Comment: What is the relationship between the ready-to-cook (RTC) poultry standard in the proposed rule and the existing Finished Product Standards (FPS)? FSIS response: Poultry products that comply with the FPS meet the definition of RTC poultry under the existing regulations; i.e., they are suitable for cooking without the need for further processing. The FPS have been in place for many years and were used to inform the OCP standards in the HIMP pilot. These OCP standards reflect OCP performance in establishments before HIMP. Establishments operating under HIMP maintained OCP defect levels that average about half the corresponding OCP performance standards. Therefore, FSIS has determined that it is not necessary to require that establishments operating under the proposed new inspection system meet prescriptive OCP performance standards in order to produce RTC poultry. Under the proposed rule, establishments operating under the proposed new inspection system would have the flexibility to implement the process controls that they have determined would best allow them to produce RTC poultry. Comment: What happens to the carcasses and parts that are rejected by the plant? FSIS response: All regulations that apply to condemned carcasses/parts would still apply under the new inspection system, e.g., denaturing and diverting away from human food. The off-line VI would verify that the plant is PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 24875 properly disposing of inedible and condemned carcasses and parts. Comment: For OCP defects under HIMP, there is a moving window in which there is non-compliance if the plant exceeds OCP standards. What about under the proposed rule? FSIS response: The Agency is moving away from using the moving window to meet OCP performance standards. Under the proposed rule, establishments would determine how they would document that they are producing RTC poultry. The Agency is not prescribing where or how establishments would address OCP defects. Comment: If establishments under the proposed new inspection system are permitted to increase the line speed, would the CI continue to detect problems? FSIS response: Analysis of HIMP data shows that CIs are able to detect fecal contamination and septicemia/toxemia at line speeds of up to 175 birds per minute (bpm) for young chickens. Comment: Did the Agency consider the effects of faster line speeds on worker safety? FSIS response: FSIS did consider potential effects on safety. The Agency is prepared to address worker safety within the bounds of its regulatory authority and will coordinate with the Occupational Safety and Health Administration (OSHA) as the regulatory process moves forward. The National Institute for Occupational Safety and Health (NIOSH) study described in the proposed rule is a start to determine what the current baseline performance indicators for worker safety in plants are before an increase in line speeds. We will use the NIOSH assessment tool and consider ways that we can supplement the NIOSH study. We are interested in comments on the effects of line speed and worker safety. Comment: Why did the Agency propose to reduce the length of the CI inspection station so that there is no room for a helper? FSIS response: Helpers are necessary under the existing inspection systems because the inspectors are sorting, and the birds have more defects. The proposed rule does not preclude an establishment from assigning a helper, but because the birds presented to the CI would have fewer defects, there is no need for a helper. Therefore, under the proposed rule, the requirement for the helper stand at the inspection CI inspection station would be removed. Comment: The Salmonella results in the HIMP report compare HIMP plants with comparison plants. How many of the HIMP plants, and how many of the comparison plants, had received E:\FR\FM\26APP1.SGM 26APP1 24876 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Proposed Rules waivers for on-line reprocessing (OLR) in each year since the HIMP pilot began? Is it possible that OLR was responsible for lower Salmonella positive rates? FSIS response: Before November 2011, FSIS did not track the date of implementation of approved waivers for OLR systems. In November 2011, all establishments with existing waivers were required to participate in the Salmonella Initiative Project (SIP) or forfeit their waivers. FSIS is able to track the dates that OLR waivers were implemented under SIP. Based on information obtained under SIP, as of March 2011, 15 of the 20 HIMP plants had waivers for OLR (75%), and 61 of the 64 comparison plants had waivers for OLR (95.3%). emcdonald on DSK29S0YB1PROD with PROPOSALS 2. Issues Raised by the Trade Association Comment: Can FSIS clarify how visible fecal contamination would be handled under the new poultry inspection system? FSIS response: An important aspect of the proposed rule is the provision that requires that all poultry establishments develop procedures to prevent fecal contamination and contamination by enteric pathogens throughout the entire process and not just cleaning up the birds at the end of the process. These written procedures would need to be incorporated into the HACCP system. Therefore, FSIS would not just be checking at the end of the line to verify that the establishment’s procedures for preventing contamination are effective. FSIS would be conducting verification activities throughout the entire process to assess whether the process is in control, including proper implementation and effective corrective actions. Findings of fecal contamination throughout the process would indicate a lack of process control. The proposed rule also requires that all poultry slaughter establishments have procedures to prevent carcasses with visible fecal contamination from entering the chiller, and that they incorporate these procedures into their HACCP system. FSIS would consider these procedures to be ineffective if a contaminated carcass entered the chiller. Comment: How were the line speeds referenced in the proposed rule determined? Do you have any additional data on how maximum line speeds for turkey plants were determined? FSIS response: The line speeds were based on our experience under HIMP. We are interested in comments and data on the proposed line speeds. VerDate Mar<15>2010 15:15 Apr 25, 2012 Jkt 226001 Comment: What are the expectations for validation under the proposed rule, particularly for the proposed changes to the time and temperature chilling requirements? FSIS response: The validation requirement under the proposed rule would be the same as what is required under the existing regulations (9 CFR 417.4(a)). There would not be any special validation requirement under the new poultry slaughter rule. Comment: Should establishments continue to apply for SIP waivers if they are interested in pursuing new technologies in their slaughter operations, or should they wait until FSIS issues a final rule on the new poultry inspection system? FSIS response: Establishments should continue to request waivers of regulations that impact slaughter operations, such as OLR and alternative chilling procedures, if they are interested in operating under such waivers. Existing SIP waivers would continue until FSIS implements the final rule. If a waiver is not addressed in any final rule resulting from this proposal, then it would remain in effect until another final rule is published. Comment: What is pre-chill? When would the pre-chill testing occur? Is post-chill testing supposed to be conducted after the final intervention? FSIS response: Pre-chill occurs just before the chilling operation, at the end of the evisceration process. The prechill testing is intended to monitor the effectiveness of all process controls up to the point of the chilling operation. Therefore, pre-chill testing should be conducted before the chiller, at the end of the evisceration process. Post-chill testing would be at the same point in the process as it is now for FSIS Salmonella and Campylobacter verification testing, that is, after all interventions. Comment: What would the parameters for faster or slower line speeds be? FSIS response: The on-line inspector would be authorized to stop the line to prevent adulterated carcasses from entering the chiller. The IIC would be authorized to slow the line. This is the same as in current HIMP and non-HIMP establishments. The on-line CI and offline VI would communicate and inform the IIC if they observe excessive food safety or non-food safety- related defects, and the IIC would assess the need to reduce the line speed or take other appropriate measures. Comment: If the final rule becomes effective, would plants be able to start running at the faster line speeds right PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 away or would there be a gradual increase in line speeds? FSIS response: To operate at faster line speeds, plants would need to comply with all of the requirements in any final rule that results from this rulemaking. The establishment’s maximum line speed would depend on the ability of the establishment to maintain process control, and whether conditions are affecting the ability of the CI to properly inspect. Implementation of the Proposed New Inspection System 1. Proposed Implementation Approach In the preamble to the proposed rule, FSIS invited interested persons to submit comments on how the Agency should implement the new poultry inspection system if it finalizes the proposed rule. The Agency specifically requested comment on whether it should phase-in the implementation of the final rule to provide additional time for small and very small establishments to adjust their operations to comply with the new requirements (77 FR 4408). The Agency also requested comments on how it can make the phased implementation most effective. In this document, FSIS is providing additional information on how it intends to implement the new poultry inspection system to solicit more focused comments on this issue. The Agency has tentatively decided that if it finalizes the proposed rule, it would then provide a time period in which all young chicken and turkey slaughter establishments would have an opportunity to contact the Agency to indicate whether they are interested in operating under the proposed new inspection system. Those establishments that choose to operate under the new inspection system would then inform the Agency concerning when they wish to begin implementing the new inspection system in their facilities. The Agency is considering giving establishments six months to decide whether they would operate under the new inspection system and up to 3 years to switch to the new system. FSIS requests comments on this proposed implementation approach and the proposed time periods. 2. Issues Raised on Implementation Comment: How would the district offices direct their resources to implement the final rule? FSIS response: The FSIS implementation plan would be coordinated from headquarters through the districts to ensure resource availability and fair and equitable E:\FR\FM\26APP1.SGM 26APP1 emcdonald on DSK29S0YB1PROD with PROPOSALS Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Proposed Rules implementation across all interested establishments. Comment: Does the Agency anticipate making additional resources available to implement a final rule, even if only on a temporary basis? FSIS response: As discussed in the preamble to the proposed rule, there would be two consumer safety inspector (CSI) positions for every slaughter evisceration line assigned to establishments that choose to adopt the new poultry slaughter inspection system, one CI and one VI (77 FR 4421– 4422). This represents a reduction in the number of inspectors because under the existing system, inspectors conduct sorting activities. At this time, the Agency does not anticipate that additional resources would be needed to implement the new poultry inspection system but would make additional resources available, such as guidance for industry and training to FSIS inspectors, as needed to ensure smooth implementation of the final rule. Comment: In the preamble to the proposed rule, the Agency estimated that 219 poultry slaughter establishments would choose to operate under the proposed new inspection system. How does the Agency intend to implement the proposed new system in all 219 establishments in a smooth and fair manner? FSIS Response: The Agency is interested in comments on the implementation phase-in and would use comments to inform implementation planning, including strategies for recruitment, staffing, training, and other actions needed to ensure FSIS readiness to implement the proposed rule in an efficient and fair manner. The Agency intends to begin implementing the proposed NPIS when it finalizes the rule. However, implementation would not take place at all eligible plants at the same time. It would be phased in over time to ensure proper FSIS inspection force readiness to successfully implement the new system. Comment: How does the Agency intend to train inspectors in the new inspection system and familiarize them with the new requirements? FSIS response: Inspectors assigned to work in poultry slaughter establishments converting to the proposed new inspection system would receive training on the new system before the establishments they are assigned to convert to the new system. The Agency is considering various approaches to ensure effectiveness and uniformity in its workforce training. Comment: Is the Agency planning to provide any type of standardized programs to assist in training the VerDate Mar<15>2010 15:15 Apr 25, 2012 Jkt 226001 establishment sorters in disease recognition and disposition for trimmable defects or is this responsibility being left up to the establishments? FSIS response: As noted in the preamble to the proposed rule, FSIS plans to convert the current instructions that it provides to Agency inspectors into guidance for industry to use to train plant sorters. Comment: Does the Agency anticipate developing a framework by which establishments or inspectors can receive quick and consistent clarification on requirements or feedback on inspectional decisions from headquarters? FSIS response: The Agency would continue to provide technical support to its workforce and industry through its standard channels. For example, FSIS would continue to encourage referring questions to its Policy Development Division through askFSIS at https:// askfsis.custhelp.com or by telephone at 1–800–233–3935. The Agency would develop appropriate instructions to inspectors as well as appropriate compliance guides. Worker Safety Issues FSIS’s direct legal authority with respect to regulating working conditions extends only to inspection personnel. The Department of Labor’s OSHA is the lead Federal agency responsible for establishment worker safety issues. However, FSIS recognizes the importance of establishment worker safety and is interested in additional information about the potential intersection of increased line speeds and worker safety. As noted in the preamble to the proposed rule, FSIS has asked NIOSH to evaluate the effects of increased line speed by collecting data from one to five non-HIMP plants that requested waivers from line speed restrictions under the Salmonella Initiative Project (SIP) (77 FR 4422). NIOSH expressed its willingness to evaluate the effects of increased production volume on employee health, with a focus on musculoskeletal disorders and acute traumatic injuries. NIOSH will prepare a report based on its findings of short, intermediate-, and long-term effects from the process modifications. We expect that the NIOSH report will also make recommendations to the Agency as appropriate. FSIS, in collaboration with OSHA, will consider the available data on employee effects collected from NIOSH activities when implementing the final rule resulting from the proposal. PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 24877 To facilitate further evaluation of this issue, FSIS requests specific comments on the effects of increased line speeds and production volume on worker safety. The Agency is particularly interested in comments on the availability of records or studies that contain data that NIOSH may be able to use to assist the Agency in analyzing the effects of increased line speed on the safety and health of employees throughout the establishment, including effects prior to and following the evisceration line. The Agency is interested in the availability of records and studies that include documentation on employees’ work, injuries, and illnesses, as well as plant production, both before and after establishments made changes to their operations to increase production volume. Such records and studies include, but are not limited to: • Human resources and payroll data for all employees on hours worked per year, department, job title, hire date, separation date, and position responsibilities; • OSHA logs, workers’ compensation claims, first reports of injury or illness, dispensary logs and records, and other injury or illness narratives for all employees; and • Daily production hours; • Results of ergonomic or industrial engineering studies, such as time-andmotion analyses that document the actual pace of work or physical stresses on workers; and • Any self-assessments of worker safety conducted by establishments. Comments on this issue should describe the type of data available, whether the data are available in an electronic or paper format, where the records are maintained, (e.g., at the establishment or at corporate headquarters), and any other information that can be used to assess the utility of the data. The comments should provide information, including contact information, on how FSIS or NIOSH can gain access to the data or studies. In addition, FSIS will continue its collaboration with NIOSH and OSHA, developing guidance materials on measures that establishments could adopt and implement to promote and better ensure worker safety. To facilitate the development of such guidance, FSIS requests comments on best practices and other measures that establishments can take to protect workers throughout the plant, including possible protective factors such as increasing the size of the workforce, rotating assignments, increased automation, or improved tools and techniques. E:\FR\FM\26APP1.SGM 26APP1 24878 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Proposed Rules Additional Public Notification FSIS will announce the availability of this Federal Register notice on-line through the FSIS Web page located at https://www.fsis.usda.gov/regulations_&_ policies/Proposed_Rules/index.asp. FSIS also will 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 our constituents and stakeholders. The Update is communicated via Listserv, a free email subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The Update also is available on the FSIS Web page. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at https://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. Done in Washington, DC on April 23, 2012. Alfred V. Almanza, Administrator. [FR Doc. 2012–10111 Filed 4–25–12; 8:45 am] BILLING CODE 3410–DM–P DEPARTMENT OF JUSTICE 28 CFR Part 16 [CPCLO Order No. 008–2012] Privacy Act of 1974; Implementation Bureau of Prisons, Department of Justice. ACTION: Notice of proposed rulemaking. AGENCY: In the Federal Register, the Bureau of Prisons (Bureau or BOP), a component of the Department of Justice, has published a notice of a revised Privacy Act system of records, Inmate Central Records System (JUSTICE/BOP– 005). In this notice of proposed rulemaking, the Bureau proposes to amend its Privacy Act regulations for the Inmate Central Records System emcdonald on DSK29S0YB1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 15:15 Apr 25, 2012 Jkt 226001 (JUSTICE/BOP–005) by now exempting this system from subsections (c)(3) and (4); (d); (e)(1), (2), (3), (4)(G), (H), and (I), (5), and (8); (f); and (g) of the Privacy Act of 1974 pursuant to 5 U.S.C. 552a(j) and (k) for the reasons set forth in the following text. The exemptions are necessary to avoid interference with the law enforcement and functions and responsibilities of the Bureau. Public comment is invited. DATES: Comments must be received by May 29, 2012. ADDRESSES: Address all comments to the Privacy Analyst, Office of Privacy and Civil Liberties, National Place Building, Suite 1000, Washington, DC 20530, or by facsimile 202–307–0693. To ensure proper handling, please reference the CPCLO Order number in your correspondence. You may review an electronic version of the proposed rule at https://www.regulations.gov. You may also submit a comment via the Internet by using the comment form for this regulation at https:// www.regulations.gov. Please include the CPCLO Order number in the subject box. Please note that the Department is requesting that electronic comments be submitted before midnight Eastern Standard Time on the day the comment period closes because https:// www.regulations.gov terminates the public’s ability to submit comments at that time. Commenters in time zones other than Eastern Standard Time may want to consider this so that their electronic comments are received. All comments sent via regular or express mail will be considered timely if postmarked on the day the comment period closes. Posting of Public Comments: Please note that all comments received are considered part of the public record and made available for public inspection online at https://www.regulations.gov and in the Department’s public docket. Such information includes personally identifying information (such as name, address, etc.,) voluntarily submitted by the commenter. If you want to submit personally identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the term ‘‘PERSONALLY IDENTIFYING INFORMATION’’ in the first paragraph of your comment. You must also place all the personally identifying information you do not want posted online or made available in the public docket in the first paragraph of your PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the term ‘‘CONFIDENTIAL BUSINESS INFORMATION’’ in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket. Personally identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Department’s public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency’s public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph. FOR FURTHER INFORMATION CONTACT: C. Darnell Stroble, Attorney-Advisor, Federal Bureau of Prisons, 202–514– 9180. SUPPLEMENTARY INFORMATION: In the Notice section of today’s Federal Register, the Bureau published a revised Privacy Act system of records notice, Inmate Central Records System (JUSTICE/BOP–005). This system assists the Attorney General and the Bureau of Prisons in meeting statutory responsibilities for the safekeeping, care and custody of incarcerated persons. It serves as the primary record system on these individuals and includes information critical to the continued safety and security of federal prisons and the public. In this rulemaking, the Bureau proposes to exempt this Privacy Act system of records from certain provisions of the Privacy Act pursuant to 5 U.S.C. 552a(j) and (k). Although this system of records was previously exempt from certain provisions of the Privacy Act pursuant to 5 U.S.C. 552a(j)(2), the Bureau is seeking additional exemptions pursuant to 5 U.S.C. 552a(j)(2), adding exemptions pursuant to 5 U.S.C. 552a(k), and consolidating the exemptions together in one location of the Code of Federal Register. Therefore, the proposed rule seeks to delete all references of the Inmate Central Records System (JUSTICE/BOP–005) from paragraphs (a) E:\FR\FM\26APP1.SGM 26APP1

Agencies

[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Proposed Rules]
[Pages 24873-24878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10111]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / 
Proposed Rules

[[Page 24873]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 381 and 500
[Docket No. FSIS-2011-0012]
RIN 0583-AD32


Modernization of Poultry Slaughter Inspection

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is extending the 
comment period for the proposed rulemaking ``Modernization of Poultry 
Slaughter Inspection'' and responding to questions and addressing 
issues that have been raised concerning the proposed rule. The comment 
period was scheduled to close on April 26, 2012. During the comment 
period, a coalition of consumer advocacy organizations and two trade 
associations representing the poultry industry asked that FSIS clarify 
certain aspects of the proposed rule to help inform their comments. 
This document summarizes the issues raised by these groups and FSIS's 
response. FSIS is also soliciting additional comments on how it should 
implement the final rule resulting from the proposal and requesting 
available data on any worker safety issues associated with increased 
line speeds.
    FSIS received a request to hold a public technical meeting on the 
proposed rule. FSIS does not believe that such a meeting would be 
useful. The Agency will, however, assess public understanding of the 
proposed rule in connection with its review and evaluation of the 
comments submitted and will respond as appropriate.

DATES: The proposed rule published January 27, 2012 (77 FR 4408) is 
extended. Comments are due May 29, 2012.

ADDRESSES: Comments may be submitted by 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 https://www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
     Mail, including floppy disks or CD-ROMs, and hand- or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture (USDA), FSIS, Docket Clerk, Patriots Plaza 3, 355 E. Street 
SW., 8-163A, Mailstop 3782, Washington, DC 20250-3700. Instructions: 
All items submitted by mail or electronic mail must include the Agency 
name and docket number FSIS-2011-0012. Comments received in response to 
this docket will be made available for public inspection and posted 
without change, including any personal information, to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Assistant 
Administrator, Office of Policy and Program Development, FSIS, U.S. 
Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 
20250-3700, (202) 720-2709.

SUPPLEMENTARY INFORMATION:

Background

    On January 27, 2012, FSIS published a proposed rule, 
``Modernization of Poultry Slaughter Inspection'' (77 FR 4408). In that 
document, the Agency proposed a new inspection system for young chicken 
and turkey slaughter establishments that would replace all of the 
existing inspection systems except for traditional inspection. Key 
elements of the proposed new inspection system include: (1) Requiring 
that establishment personnel sort carcasses and remove unacceptable 
carcasses and parts before the birds are presented to the FSIS carcass 
inspector; (2) reducing the number of on-line carcass inspectors to 
one; (3) permitting faster line speeds than are permitted under the 
existing inspection systems; and (4) replacing the existing Finished 
Product Standards (FPS) with a requirement that establishments that 
operate under the new inspection system maintain records to document 
that the products resulting from their slaughter operations meet the 
definition of ready-to-cook poultry. In addition to the proposed new 
inspection system, FSIS also proposed changes that would require, among 
other things, that all establishments that slaughter poultry other than 
ratites develop, implement, and maintain written procedures to prevent 
contamination of carcasses and parts by enteric pathogens and fecal 
material, and that they incorporate these procedures into their HACCP 
plan or sanitation standard operating procedures (SOP) or other 
prerequisite programs.
    During the comment period for the proposal, FSIS officials met with 
representatives from a coalition of consumer advocacy organizations and 
two trade associations representing the poultry industry. The consumer 
advocacy coalition and one of the trade associations had requested that 
FSIS clarify certain aspects of the proposed rule to inform their 
comments on the proposal. Because the issues addressed in these 
meetings may be relevant to the development of comments from other 
stakeholders, a brief summary of these issues and the Agency's response 
are described below. The other trade association requested that FSIS 
provide additional information on how the Agency intends to implement 
the proposed new poultry inspection system. The groups submitted 
written questions to the Agency to consider before each meeting. The 
issues raised on implementation are summarized in a separate section of 
this document that outlines and requests comments on how the Agency 
plans to implement the final rule.

Summary of Issues Raised and FSIS Response

    In addition to the questions outlined below, certain members of 
consumer advocacy organizations requested that FSIS hold a public 
technical meeting on the proposed rule. FSIS is clarifying certain 
aspects of the proposed rule in this Federal Register notice and will 
assess public understanding of the proposed rule in connection with its 
review and evaluation of the comments submitted. The Agency will 
provide any needed clarification if a final rule is adopted.
    Following is a summary of the issues raised and FSIS's response.

[[Page 24874]]

1. Issues Raised by the Consumer Advocacy Coalition

    Comment: Why does FSIS believe that it is preferable for plant 
employees to sort carcasses?
    FSIS response: Under the existing inspection systems, on-line 
inspectors conduct activities that do not have a direct impact on 
public health. If the proposal is finalized, and the establishment 
conducts sorting activities, the only birds presented to the carcass 
inspector (CI) would be those that are likely to pass inspection. 
Therefore, the CI will be able to focus on food safety-related 
activities, such as verifying that carcasses affected by septicemia or 
toxemia or contaminated with visible fecal material do not enter the 
chiller. For these reasons, the Agency is proposing to remove certain 
on-line inspection activities that are not directly related to public 
health.
    Comment: Is there any guarantee that FSIS inspectors would be 
performing more food safety-related activities under the proposed new 
inspection system?
    FSIS response: Yes, generally inspectors would be performing more 
food safety-related activities. There are three important aspects of 
the proposed rule that would allow FSIS inspectors to conduct more food 
safety-related activities. First, because the on-line CI would not be 
responsible for sorting carcasses for quality-related defects, the 
amount of time that the CI spends focusing on food safety-related 
activities would increase. Second, under the proposed new inspection 
system, the offline verification inspector (VI) would primarily conduct 
food safety-related activities, such as verifying compliance with HACCP 
and sanitation SOP requirements and collecting product samples. Third, 
because FSIS considers contamination by enteric pathogens and fecal 
contamination to be hazards that are reasonably likely to occur, FSIS 
is proposing to require that all establishments that slaughter poultry 
have written programs to address sanitary dressing procedures, and 
that, at a minimum, these procedures include microbiological testing at 
pre-chill and post-chill to monitor process control. In addition to 
conducting verification checks on carcasses, FSIS off-line inspectors 
would be reviewing the establishment's records and test results to 
verify that the establishment maintains process control.
    Comment: What type of training would FSIS require for establishment 
employees assigned to sort carcasses?
    FSIS response: The proposed rule does not prescribe training for 
establishment employees. However, as noted in the preamble to the 
proposed rule, FSIS expects to convert the current instructions that it 
provides to Agency inspectors into guidance for industry to use to 
train plant sorters (77 FR 4419).
    Comment: What would establishment employees be required to do as 
part of their sorting activities?
    FSIS response: Should the rule become final, establishment sorters 
would be required to identify carcasses with septicemia/toxemia and 
other condemnable conditions and to remove them from the line before 
they reach the CI. Establishment employees would also need to conduct 
trimming and re-processing before the birds reach the CI.
    Comment: Will establishment employees need to look inside the bird 
as part of their sorting responsibilities?
    FSIS response: Septicemic/toxemic birds exhibit signs on the 
outside of the carcass, so there is no need to look at the viscera. The 
regulations that prescribe conditions for condemnation in 9 CFR 381.81-
381.93 would still apply. Establishment personnel would need to conduct 
sorting activities to address these condemnable conditions before the 
birds reach the CI. The conditions described in these regulations can 
be readily identified by examining the outside of the carcass.
    Lesions on the viscera do not require condemnation of the entire 
carcass except for lesions associated with visceral leukosis. The 
proposed rule provides for a 300-bird inspection of young chickens with 
the viscera (77 CFR 4421-4422). If the inspector finds signs or 
symptoms associated with visceral leukosis, then the entire flock would 
be inspected for the disease. All growers vaccinate birds for visceral 
leukosis. Therefore, it is seen only on rare occasions if the vaccine 
fails.
    Comment: How does the proposed rule address other consumer 
protection (OCP) issues, such as digestive tract contents found on 
products, that may affect internal parts of the carcass?
    FSIS response: There is a difference between fecal material and 
ingesta as digestive tract contents. We have no evidence to show that 
ingesta carries the same microbes as fecal contamination. Under the 
proposal, FSIS would enforce OCP processing defects that are associated 
with digestive tract contents, other than fecal contamination, in 
enforcing the ready-to-cook (RTC) poultry standard.
    Comment: Where would the establishment's critical control point 
(CCP) for visible fecal contamination be located?
    FSIS response: FSIS does not prescribe where establishments must 
locate CCPs. The CI would be located before the chiller. Visible fecal 
contamination would need to be removed before the carcass is presented 
to the CI. The VI would be conducting verification checks for fecal 
contamination off-line. If the VI detects fecal contamination offline, 
the plant has exceeded the zero tolerance for visible fecal 
contamination.
    The present inspection system is similar to the proposed system in 
that there are inspectors located upstream, and zero tolerance is 
enforced at a point at final wash, before the carcass enters the 
chiller. However, under the proposed new system the CI is more likely 
to observe visible fecal contamination because the carcasses would be 
free from animal diseases and trim and processing defects.
    Comment: Under the proposed rule, can FSIS take regulatory action 
throughout the entire dressing process?
    FSIS Response: The proposed rule would require that establishments 
develop, implement, and maintain procedures to address contamination by 
enteric pathogens and fecal material throughout the entire slaughter 
and dressing process. Through inspection activities, FSIS would ensure 
that the establishment's procedures are effective, and the Agency would 
take appropriate regulatory action when necessary.
    Comment: Would there be an approval process for the establishment's 
procedures to prevent contamination with enteric pathogens and fecal 
material?
    FSIS response: There would be no pre-approval of an establishment's 
procedures. However, establishments would need to ensure that their 
procedures for preventing contamination are effective. To verify that 
an establishment's procedures are effective, FSIS would consider: (1) 
The microbiological data that the establishment would be required to 
collect pre-chill and post-chill to demonstrate process control; (2) 
presence of visible fecal contamination; and (3) FSIS sampling results 
for Salmonella and Campylobacter.
    Comment: What was the basis for the baseline sampling numbers 
presented in the preamble to the proposed rule (74 FR 4442)?
    FSIS response: The estimates for sampling come from the economic 
analysis and reflect what we estimate to be the amount of sampling that 
plants would conduct if the proposed rule is adopted by the Agency. We 
are not proposing to prescribe how often establishments must test. 
Establishments would need to determine the frequency and type of 
sampling that would be sufficient to

[[Page 24875]]

demonstrate that they are maintaining process control.
    Comment: Why is FSIS not mandating a frequency for testing?
    FSIS response: As stated in the preamble to the proposed rule, FSIS 
is proposing to require that an establishment's sampling frequency be 
adequate to monitor the effectiveness of its process control for 
enteric pathogens (77 FR 4428). The frequency with which establishments 
would need to conduct such testing would depend on a number of factors, 
including their production volume, the source of their flocks, their 
slaughter and dressing process, and the consistency of their microbial 
test results over time. Because the testing frequency would be an 
integral part of an establishment's HACCP system verification 
procedures, establishments would need to collect and maintain data to 
demonstrate that their testing frequency is adequate to verify the 
effectiveness of their process control procedures.
    Comment: Why did the Agency propose two points for microbiological 
testing instead of three?
    FSIS response: As noted in the preamble to the proposed rule, FSIS 
had considered requiring testing at three points in the process, i.e., 
re-hang, pre-chill and post-chill (77 FR 4428). The proposed rule 
provides for testing at pre-chill and post-chill because the Agency 
tentatively concluded that verification testing conducted at these two 
points would provide the evidence establishments need to verify that 
their process control measures are effective in preventing carcasses 
from becoming contaminated with pathogens. In the preamble to the 
proposed rule, the Agency explained that it considered requiring a 
third verification test at the re-hang position to monitor the incoming 
load of pathogens but tentatively decided that it was not necessary to 
impose the additional costs that would be associated with testing at 
this point (77 FR 4428). FSIS also considered requiring only one 
verification test at any position along the production line to provide 
maximum flexibility but concluded this approach may not be sufficient 
to monitor the effectiveness of an establishment's procedures to 
prevent contamination throughout the slaughter and dressing operation. 
The Agency requests comments on these alternatives.
    Comment: Can CI inspectors stop or slow the line?
    FSIS response: If the CI observes a condemnable condition, either 
food safety or generalized OCP condition requiring condemnation of the 
entire carcass, the CI would be authorized to stop the line to prevent 
such carcasses from entering the chiller. The CI would communicate the 
findings to the VI and inspector-in-charge (IIC). The IIC would 
consider available data to reset the line speed. Line speed would be 
determined by IIC's assessment of the frequency of carcass defects 
identified by the CI and the VI and the plant's control of its 
processes.
    Comment: Would offline inspectors be available to visually inspect 
carcasses under the proposed new system.
    FSIS response: The off-line VI would be checking carcasses to 
verify that they do not contain food safety-related contamination or 
defects.
    Comment: How many HACCP verification activities would occur under 
the new system versus the old system?
    FSIS Response: HACCP and sanitation verification activities would 
be a higher fraction of inspection activities under the proposed new 
inspection system as the Agency reduces its focus on quality and other 
OCP defects.
    Comment: What is the relationship between the ready-to-cook (RTC) 
poultry standard in the proposed rule and the existing Finished Product 
Standards (FPS)?
    FSIS response: Poultry products that comply with the FPS meet the 
definition of RTC poultry under the existing regulations; i.e., they 
are suitable for cooking without the need for further processing. The 
FPS have been in place for many years and were used to inform the OCP 
standards in the HIMP pilot. These OCP standards reflect OCP 
performance in establishments before HIMP. Establishments operating 
under HIMP maintained OCP defect levels that average about half the 
corresponding OCP performance standards. Therefore, FSIS has determined 
that it is not necessary to require that establishments operating under 
the proposed new inspection system meet prescriptive OCP performance 
standards in order to produce RTC poultry. Under the proposed rule, 
establishments operating under the proposed new inspection system would 
have the flexibility to implement the process controls that they have 
determined would best allow them to produce RTC poultry.
    Comment: What happens to the carcasses and parts that are rejected 
by the plant?
    FSIS response: All regulations that apply to condemned carcasses/
parts would still apply under the new inspection system, e.g., 
denaturing and diverting away from human food. The off-line VI would 
verify that the plant is properly disposing of inedible and condemned 
carcasses and parts.
    Comment: For OCP defects under HIMP, there is a moving window in 
which there is non-compliance if the plant exceeds OCP standards. What 
about under the proposed rule?
    FSIS response: The Agency is moving away from using the moving 
window to meet OCP performance standards. Under the proposed rule, 
establishments would determine how they would document that they are 
producing RTC poultry. The Agency is not prescribing where or how 
establishments would address OCP defects.
    Comment: If establishments under the proposed new inspection system 
are permitted to increase the line speed, would the CI continue to 
detect problems?
    FSIS response: Analysis of HIMP data shows that CIs are able to 
detect fecal contamination and septicemia/toxemia at line speeds of up 
to 175 birds per minute (bpm) for young chickens.
    Comment: Did the Agency consider the effects of faster line speeds 
on worker safety?
    FSIS response: FSIS did consider potential effects on safety. The 
Agency is prepared to address worker safety within the bounds of its 
regulatory authority and will coordinate with the Occupational Safety 
and Health Administration (OSHA) as the regulatory process moves 
forward. The National Institute for Occupational Safety and Health 
(NIOSH) study described in the proposed rule is a start to determine 
what the current baseline performance indicators for worker safety in 
plants are before an increase in line speeds. We will use the NIOSH 
assessment tool and consider ways that we can supplement the NIOSH 
study. We are interested in comments on the effects of line speed and 
worker safety.
    Comment: Why did the Agency propose to reduce the length of the CI 
inspection station so that there is no room for a helper?
    FSIS response: Helpers are necessary under the existing inspection 
systems because the inspectors are sorting, and the birds have more 
defects. The proposed rule does not preclude an establishment from 
assigning a helper, but because the birds presented to the CI would 
have fewer defects, there is no need for a helper. Therefore, under the 
proposed rule, the requirement for the helper stand at the inspection 
CI inspection station would be removed.
    Comment: The Salmonella results in the HIMP report compare HIMP 
plants with comparison plants. How many of the HIMP plants, and how 
many of the comparison plants, had received

[[Page 24876]]

waivers for on-line reprocessing (OLR) in each year since the HIMP 
pilot began? Is it possible that OLR was responsible for lower 
Salmonella positive rates?
    FSIS response: Before November 2011, FSIS did not track the date of 
implementation of approved waivers for OLR systems. In November 2011, 
all establishments with existing waivers were required to participate 
in the Salmonella Initiative Project (SIP) or forfeit their waivers. 
FSIS is able to track the dates that OLR waivers were implemented under 
SIP. Based on information obtained under SIP, as of March 2011, 15 of 
the 20 HIMP plants had waivers for OLR (75%), and 61 of the 64 
comparison plants had waivers for OLR (95.3%).

2. Issues Raised by the Trade Association

    Comment: Can FSIS clarify how visible fecal contamination would be 
handled under the new poultry inspection system?
    FSIS response: An important aspect of the proposed rule is the 
provision that requires that all poultry establishments develop 
procedures to prevent fecal contamination and contamination by enteric 
pathogens throughout the entire process and not just cleaning up the 
birds at the end of the process. These written procedures would need to 
be incorporated into the HACCP system. Therefore, FSIS would not just 
be checking at the end of the line to verify that the establishment's 
procedures for preventing contamination are effective. FSIS would be 
conducting verification activities throughout the entire process to 
assess whether the process is in control, including proper 
implementation and effective corrective actions. Findings of fecal 
contamination throughout the process would indicate a lack of process 
control. The proposed rule also requires that all poultry slaughter 
establishments have procedures to prevent carcasses with visible fecal 
contamination from entering the chiller, and that they incorporate 
these procedures into their HACCP system. FSIS would consider these 
procedures to be ineffective if a contaminated carcass entered the 
chiller.
    Comment: How were the line speeds referenced in the proposed rule 
determined? Do you have any additional data on how maximum line speeds 
for turkey plants were determined?
    FSIS response: The line speeds were based on our experience under 
HIMP. We are interested in comments and data on the proposed line 
speeds.
    Comment: What are the expectations for validation under the 
proposed rule, particularly for the proposed changes to the time and 
temperature chilling requirements?
    FSIS response: The validation requirement under the proposed rule 
would be the same as what is required under the existing regulations (9 
CFR 417.4(a)). There would not be any special validation requirement 
under the new poultry slaughter rule.
    Comment: Should establishments continue to apply for SIP waivers if 
they are interested in pursuing new technologies in their slaughter 
operations, or should they wait until FSIS issues a final rule on the 
new poultry inspection system?
    FSIS response: Establishments should continue to request waivers of 
regulations that impact slaughter operations, such as OLR and 
alternative chilling procedures, if they are interested in operating 
under such waivers. Existing SIP waivers would continue until FSIS 
implements the final rule. If a waiver is not addressed in any final 
rule resulting from this proposal, then it would remain in effect until 
another final rule is published.
    Comment: What is pre-chill? When would the pre-chill testing occur? 
Is post-chill testing supposed to be conducted after the final 
intervention?
    FSIS response: Pre-chill occurs just before the chilling operation, 
at the end of the evisceration process. The pre-chill testing is 
intended to monitor the effectiveness of all process controls up to the 
point of the chilling operation. Therefore, pre-chill testing should be 
conducted before the chiller, at the end of the evisceration process. 
Post-chill testing would be at the same point in the process as it is 
now for FSIS Salmonella and Campylobacter verification testing, that 
is, after all interventions.
    Comment: What would the parameters for faster or slower line speeds 
be?
    FSIS response: The on-line inspector would be authorized to stop 
the line to prevent adulterated carcasses from entering the chiller. 
The IIC would be authorized to slow the line. This is the same as in 
current HIMP and non-HIMP establishments. The on-line CI and off-line 
VI would communicate and inform the IIC if they observe excessive food 
safety or non-food safety- related defects, and the IIC would assess 
the need to reduce the line speed or take other appropriate measures.
    Comment: If the final rule becomes effective, would plants be able 
to start running at the faster line speeds right away or would there be 
a gradual increase in line speeds?
    FSIS response: To operate at faster line speeds, plants would need 
to comply with all of the requirements in any final rule that results 
from this rulemaking. The establishment's maximum line speed would 
depend on the ability of the establishment to maintain process control, 
and whether conditions are affecting the ability of the CI to properly 
inspect.

Implementation of the Proposed New Inspection System

1. Proposed Implementation Approach

    In the preamble to the proposed rule, FSIS invited interested 
persons to submit comments on how the Agency should implement the new 
poultry inspection system if it finalizes the proposed rule. The Agency 
specifically requested comment on whether it should phase-in the 
implementation of the final rule to provide additional time for small 
and very small establishments to adjust their operations to comply with 
the new requirements (77 FR 4408). The Agency also requested comments 
on how it can make the phased implementation most effective. In this 
document, FSIS is providing additional information on how it intends to 
implement the new poultry inspection system to solicit more focused 
comments on this issue.
    The Agency has tentatively decided that if it finalizes the 
proposed rule, it would then provide a time period in which all young 
chicken and turkey slaughter establishments would have an opportunity 
to contact the Agency to indicate whether they are interested in 
operating under the proposed new inspection system. Those 
establishments that choose to operate under the new inspection system 
would then inform the Agency concerning when they wish to begin 
implementing the new inspection system in their facilities. The Agency 
is considering giving establishments six months to decide whether they 
would operate under the new inspection system and up to 3 years to 
switch to the new system. FSIS requests comments on this proposed 
implementation approach and the proposed time periods.

2. Issues Raised on Implementation

    Comment: How would the district offices direct their resources to 
implement the final rule?
    FSIS response: The FSIS implementation plan would be coordinated 
from headquarters through the districts to ensure resource availability 
and fair and equitable

[[Page 24877]]

implementation across all interested establishments.
    Comment: Does the Agency anticipate making additional resources 
available to implement a final rule, even if only on a temporary basis?
    FSIS response: As discussed in the preamble to the proposed rule, 
there would be two consumer safety inspector (CSI) positions for every 
slaughter evisceration line assigned to establishments that choose to 
adopt the new poultry slaughter inspection system, one CI and one VI 
(77 FR 4421-4422). This represents a reduction in the number of 
inspectors because under the existing system, inspectors conduct 
sorting activities. At this time, the Agency does not anticipate that 
additional resources would be needed to implement the new poultry 
inspection system but would make additional resources available, such 
as guidance for industry and training to FSIS inspectors, as needed to 
ensure smooth implementation of the final rule.
    Comment: In the preamble to the proposed rule, the Agency estimated 
that 219 poultry slaughter establishments would choose to operate under 
the proposed new inspection system. How does the Agency intend to 
implement the proposed new system in all 219 establishments in a smooth 
and fair manner?
    FSIS Response: The Agency is interested in comments on the 
implementation phase-in and would use comments to inform implementation 
planning, including strategies for recruitment, staffing, training, and 
other actions needed to ensure FSIS readiness to implement the proposed 
rule in an efficient and fair manner. The Agency intends to begin 
implementing the proposed NPIS when it finalizes the rule. However, 
implementation would not take place at all eligible plants at the same 
time. It would be phased in over time to ensure proper FSIS inspection 
force readiness to successfully implement the new system.
    Comment: How does the Agency intend to train inspectors in the new 
inspection system and familiarize them with the new requirements?
    FSIS response: Inspectors assigned to work in poultry slaughter 
establishments converting to the proposed new inspection system would 
receive training on the new system before the establishments they are 
assigned to convert to the new system. The Agency is considering 
various approaches to ensure effectiveness and uniformity in its 
workforce training.
    Comment: Is the Agency planning to provide any type of standardized 
programs to assist in training the establishment sorters in disease 
recognition and disposition for trimmable defects or is this 
responsibility being left up to the establishments?
    FSIS response: As noted in the preamble to the proposed rule, FSIS 
plans to convert the current instructions that it provides to Agency 
inspectors into guidance for industry to use to train plant sorters.
    Comment: Does the Agency anticipate developing a framework by which 
establishments or inspectors can receive quick and consistent 
clarification on requirements or feedback on inspectional decisions 
from headquarters?
    FSIS response: The Agency would continue to provide technical 
support to its workforce and industry through its standard channels. 
For example, FSIS would continue to encourage referring questions to 
its Policy Development Division through askFSIS at https://askfsis.custhelp.com or by telephone at 1-800-233-3935. The Agency 
would develop appropriate instructions to inspectors as well as 
appropriate compliance guides.

Worker Safety Issues

    FSIS's direct legal authority with respect to regulating working 
conditions extends only to inspection personnel. The Department of 
Labor's OSHA is the lead Federal agency responsible for establishment 
worker safety issues. However, FSIS recognizes the importance of 
establishment worker safety and is interested in additional information 
about the potential intersection of increased line speeds and worker 
safety.
    As noted in the preamble to the proposed rule, FSIS has asked NIOSH 
to evaluate the effects of increased line speed by collecting data from 
one to five non-HIMP plants that requested waivers from line speed 
restrictions under the Salmonella Initiative Project (SIP) (77 FR 
4422). NIOSH expressed its willingness to evaluate the effects of 
increased production volume on employee health, with a focus on 
musculoskeletal disorders and acute traumatic injuries. NIOSH will 
prepare a report based on its findings of short-, intermediate-, and 
long-term effects from the process modifications. We expect that the 
NIOSH report will also make recommendations to the Agency as 
appropriate. FSIS, in collaboration with OSHA, will consider the 
available data on employee effects collected from NIOSH activities when 
implementing the final rule resulting from the proposal.
    To facilitate further evaluation of this issue, FSIS requests 
specific comments on the effects of increased line speeds and 
production volume on worker safety. The Agency is particularly 
interested in comments on the availability of records or studies that 
contain data that NIOSH may be able to use to assist the Agency in 
analyzing the effects of increased line speed on the safety and health 
of employees throughout the establishment, including effects prior to 
and following the evisceration line. The Agency is interested in the 
availability of records and studies that include documentation on 
employees' work, injuries, and illnesses, as well as plant production, 
both before and after establishments made changes to their operations 
to increase production volume. Such records and studies include, but 
are not limited to:
     Human resources and payroll data for all employees on 
hours worked per year, department, job title, hire date, separation 
date, and position responsibilities;
     OSHA logs, workers' compensation claims, first reports of 
injury or illness, dispensary logs and records, and other injury or 
illness narratives for all employees; and
     Daily production hours;
     Results of ergonomic or industrial engineering studies, 
such as time-and-motion analyses that document the actual pace of work 
or physical stresses on workers; and
     Any self-assessments of worker safety conducted by 
establishments.
    Comments on this issue should describe the type of data available, 
whether the data are available in an electronic or paper format, where 
the records are maintained, (e.g., at the establishment or at corporate 
headquarters), and any other information that can be used to assess the 
utility of the data. The comments should provide information, including 
contact information, on how FSIS or NIOSH can gain access to the data 
or studies.
    In addition, FSIS will continue its collaboration with NIOSH and 
OSHA, developing guidance materials on measures that establishments 
could adopt and implement to promote and better ensure worker safety. 
To facilitate the development of such guidance, FSIS requests comments 
on best practices and other measures that establishments can take to 
protect workers throughout the plant, including possible protective 
factors such as increasing the size of the workforce, rotating 
assignments, increased automation, or improved tools and techniques.

[[Page 24878]]

Additional Public Notification

    FSIS will announce the availability of this Federal Register notice 
on-line through the FSIS Web page located at https://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.
    FSIS also will 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 our constituents and 
stakeholders. The Update is communicated via Listserv, a free email 
subscription service consisting of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals who have requested to be included. 
The Update also is available on the FSIS Web page. Through Listserv and 
the Web page, FSIS is able to provide information to a much broader, 
more diverse audience.
    In addition, FSIS offers an email subscription service which 
provides automatic and customized access to selected food safety news 
and information. This service is available at https://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.

    Done in Washington, DC on April 23, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-10111 Filed 4-25-12; 8:45 am]
BILLING CODE 3410-DM-P
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