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/register/2013/08/28/2013-20995A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2013-08-28.xml --- 78 167 Wednesday, August 28, 2013 Contents Agriculture Agriculture Department See Food Safety and Inspection Service See Forest Service Air Force Air Force Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53134 2013-21001 Alcohol Tobacco Tax Alcohol and Tobacco Tax and Trade Bureau PROPOSED RULES Viticultural Areas: Eagle Peak Mendocino County and Mendocino and Redwood Valley;
Establishment and Realignment, 53103-53104 2013-20950 Army Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53134-53135 2013-21012 Centers Disease Centers for Disease Control and Prevention NOTICES Charter Renewals: Advisory Board on Radiation and Worker Health, 53147 2013-20974 Meetings: National Center for Health Statistics, Classifications and Public Health Data Standards, 53148-53149 2013-20976 Subcommittee for Dose Reconstruction Reviews, Advisory Board on Radiation and Worker Health, etc., 53147-53148 2013-20973 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Medicare and Medicaid Programs:
Continued Approval of American Osteopathic Association/Healthcare Facilities Accreditation Program Hospital Accreditation Program, 53149-53150 2013-21008 Children Children and Families Administration NOTICES Meetings: Advisory Committee on the Maternal, Infant, and Early Childhood Home Visiting Program Evaluation, 53150-53151 2013-20725 Coast Guard Coast Guard PROPOSED RULES Drawbridge Operations: Hackensack River, Kearny and Jersey City, NJ, 53104-53107 2013-20685 Passaic River, Kearny and Newark, NJ, 53107-53109 2013-20684 Security Zones:
Naval Base Point Loma, Naval Mine Anti Submarine Warfare Command, San Diego Bay, San Diego, CA, 53109-53113 2013-20781 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Oceanic and Atmospheric Administration Defense Department Defense Department See Air Force Department See Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53132-53133 2013-21003 Meetings: National Commission on the Structure of the Air Force, 53133-53134 2013-20991 Department of Transportation See Pipeline and Hazardous Materials Safety Administration Energy Department Energy Department See Energy Information Administration See Federal Energy Regulatory Commission NOTICES Meetings:
Environmental Management Site-Specific Advisory Board, Nevada, 53135 2013-20977 Energy Information Energy Information Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53135-53137 2013-20978 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Nevada; Regional Haze Federal Implementation Plan; Extension of BART Compliance Date for Reid Gardner Generating Station, 53033-53038 2013-20749 Air Quality:
Definition of Volatile Organic Compounds; Exclusion of trans 1-chloro-3,3,3-trifluoroprop-1-ene, 53029-53033 2013-21014 Pesticide Tolerances: Ethyl-2E,4Z-Decadienoate (Pear Ester), 53051-53054 2013-21019 Halosulfuron-methyl, 53047-53051 2013-20906 Pyraclostrobin, 53039-53047 2013-20921 Sanctions; Determinations: California; San Joaquin Valley, 53038-53039 2013-21011 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; San Joaquin Valley;
Contingency Measures for the 1997 PM2.5 Standards, 53113-53124 2013-21010 NOTICES Draft IRIS Carcinogenicity Assessment for Ethylene Oxide, 53138-53139 2013-20913 Pesticide Registrations: Applications for New Uses, 53139-53141 2013-21017 Requests to Voluntarily Cancel Certain Pesticide Registrations, 53141-53143 2013-21021 Proposed Consent Decrees, Clean Air Act Citizen Suit, 53143-53144 2013-21023 Requests for Nominations: Experts to Review the Draft Toxicological Assessments for Ammonia, Trimethylbenzenes, etc., 53144-53146 2013-20911 Executive Office of the President See Presidential Documents See Trade Representative, Office of United States Export Import Export-Import Bank NOTICES Applications for Long-Term Loan or Financial Guarantee in Excess of $100 Million, 53146 2013-20901 Federal Aviation Federal Aviation Administration RULES Pilot Certification and Qualification Requirements for Air Carrier Operations;
Correction, 53025-53026 2013-20962 PROPOSED RULES Airworthiness Directives: Bombardier, Inc. Airplanes, 53080-53083 2013-20968 The Boeing Company Airplanes, 53078-53080 2013-20969 NOTICES Land Releases: Penn Yan Airport, 53184 2013-21002 Petitions for Exemption; Summaries, 53185-53186 2013-20970 2013-20971 Federal Communications Federal Communications Commission RULES Radio Broadcasting Services: Chillicothe, Dublin, Hillsboro, and Marion, OH, 53054-53055 2013-21031 PROPOSED RULES First Responder Network Authority Filing, 53124-53126 2013-21040 Federal Energy Federal Energy Regulatory Commission NOTICES Complaints:
Flint Hills Resources Alaska, LLC v. BP Pipelines (Alaska) Inc., et al., 53137 2013-20924 Meetings: South Carolina Public Service Authority; Santee-Cooper Biological Opinion, 53138 2013-20923 Texas Eastern Transmission, LP; Technical Conference, 53137-53138 2013-20925 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.: I-94 East-West Corridor, Milwaukee County, WI, 53186-53187 2013-20964 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control:
Acquisitions of Shares of a Bank or Bank Holding Company, 53146 2013-20998 Federal Transit Federal Transit Administration NOTICES Meetings: Alternatives Analysis of the GA 400 Transit Initiative, Fulton County, GA, 53187-53189 2013-20996 Fish Fish and Wildlife Service RULES Endangered and Threatened Wildlife and Plants: Impact Analyses of Critical Habitat, 53058-53076 2013-20994 Migratory Bird Hunting: Early Seasons and Bag and Possession Limits for Certain Migratory Game Birds in the Contiguous United States, etc., 53200-53216 2013-20984 Migratory Bird Hunting Regulations on Certain Federal Indian Reservations and Ceded Lands for the 2013-14 Early Season, 53218-53229 2013-20981 NOTICES Endangered and Threatened Wildlife and Plants:
Recovery Plan for Phyllostegia hispida; Addendum to the Molokai Plant Cluster Recovery Plan, 53155-53156 2013-20965 Meetings: Sport Fishing and Boating Partnership Council, 53156 2013-20937 Permits: Endangered and Threatened Species, 53157-53158 2013-20966 Food and Drug Food and Drug Administration NOTICES Draft Guidance for Industry and Staff; Availability: Applicability of Good Laboratory Practice in Premarket Device Submissions; Questions and Answers, 53151-53152 2013-20916 Prescription Drug User Fee Rates for Fiscal Year 2014;
Correction, 53152 2013-20958 Food Safety Food Safety and Inspection Service RULES Salmonella Verification Sampling Program: Analysis of Raw Beef for Shiga Toxin-Producing Escherichia coli and Salmonella, 53017-53020 2013-20995 Foreign Assets Foreign Assets Control Office NOTICES Blocking and Unblocking of Persons and Properties, 53191-53193 2013-20982 2013-20983 Foreign Trade Foreign-Trade Zones Board NOTICES Reorganizations under Alternative Site Frameworks: Proposed Foreign-Trade Zone, Ontario County, NY, 53127-53128 2013-21030 Forest Forest Service NOTICES Meetings:
Delta-Bienville Resource Advisory Committee, 53127 2013-20963 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53146-53147 2013-20959 Health Resources Health Resources and Services Administration NOTICES Meetings:
Advisory Committee on the Maternal, Infant, and Early Childhood Home Visiting Program Evaluation, 53150-53151 2013-20725 Homeland Homeland Security Department See Coast Guard Indian Affairs Indian Affairs Bureau PROPOSED RULES Leasing of Osage Reservation Lands for Oil and Gas Mining, 53083-53103 2013-20764 Interior Interior Department See Fish and Wildlife Service See Indian Affairs Bureau See Land Management Bureau Internal Revenue Internal Revenue Service RULES Regulations Enabling Elections for Certain Transaction under Section 336(e);
Correction, 53026-53027 2013-20491 2013-20495 NOTICES Meetings: Tax Exempt and Government Entities Division Advisory Group, 53194 2013-20951 International Trade Adm International Trade Administration NOTICES Antidumping and Countervailing Duty Administrative Reviews; Results, Extensions, Amendments, etc., 53128-53132 2013-21022 International Trade Com International Trade Commission NOTICES Investigations; Terminations, Modifications and Rulings, etc.: Semiconductor Chips with Dram Circuitry, and Modules and Products Containing Same, 53159 2013-20952 Judicial Conference Judicial Conference of the United States NOTICES Meetings:
Committee on Rules of Practice and Procedure, 53159 2013-20980 Labor Department Labor Department See Occupational Safety and Health Administration Land Land Management Bureau NOTICES Alaska Native Claims Selection, 53158 2013-20989 Meetings: Central Montana Resource Advisory Council, 53158 2013-20967 National Credit National Credit Union Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53161-53172 2013-20929 2013-20931 2013-20932 2013-20933 2013-20936 2013-20938 2013-20939 2013-20940 2013-20941 2013-20942 2013-20943 2013-20946 2013-20947 2013-20948 National Highway National Highway Traffic Safety Administration NOTICES Petitions for Inconsequential Noncompliance;
Denials: Dorel Juvenile Group, 53189-53190 2013-20960 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Palliative Care; Conversations Matter Evaluation, 53152-53153 2013-21005 Exclusive Patent Licenses: Use of Exenatide for the Treatment of Neurodegenerative Diseases, 53153-53154 2013-20945 Meetings: National Cancer Institute, 53154-53155 2013-20944 National Intelligence National Intelligence, Office of the National Director NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 53172-53173 2013-20992 National Oceanic National Oceanic and Atmospheric Administration RULES Endangered and Threatened Wildlife and Plants: Impact Analyses of Critical Habitat, 53058-53076 2013-20994 Fisheries of the Exclusive Economic Zone Off Alaska: Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area, 53076-53077 2013-21018 NOTICES Meetings: Mid-Atlantic Fishery Management Council; Correction, 53132 2013-20987 Nuclear Regulatory Nuclear Regulatory Commission RULES Branch Technical Position on the Import of Non-U.S.
Origin Radioactive Sources, 53020-53025 2013-20975 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53173 2013-20953 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Standard for Welding, Cutting, and Brazing, 53159-53161 2013-20954 Office of the Director of National Intelligence See National Intelligence, Office of the National Director Office of United States Trade Representative See Trade Representative, Office of United States Peace Peace Corps PROPOSED RULES Freedom of Information Act Administration;
Correction, 53083 2013-20926 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53173-53174 2013-20927 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Pipeline Safety: Recall on Leak Repair Clamps Due to Defective Seal, 53190-53191 2013-20910 Postal Service Postal Service RULES Balloting Materials Postage, 53027-53029 2013-20799 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: 50th Anniversary of the March on Washington for Jobs and Freedom (Proc. 9004), 53235-53236 2013-21189 Women's Equality Day (Proc. 9003), 53231-53234 2013-21188 Railroad Retirement Railroad Retirement Board NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 53174-53175 2013-20979 Securities Securities and Exchange Commission NOTICES Applications: Northwestern Mutual Life Insurance Co., et al., 53175-53179 2013-20955 Self-Regulatory Organizations; Proposed Rule Changes: New York Stock Exchange, LLC, 53181-53183 2013-20956 NASDAQ Stock Market, LLC, 53179-53181 2013-20934 Surface Transportation Surface Transportation Board RULES Fees for Services Performed in Connection with Licensing and Related Services; 2013 Update, 53055-53058 2013-20999 Trade Representative Trade Representative, Office of United States NOTICES Trans-Pacific Partnership Agreement;
Interim Environmental Review, 53183-53184 2013-20930 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Transit Administration See National Highway Traffic Safety Administration See Pipeline and Hazardous Materials Safety Administration See Surface Transportation Board Treasury Treasury Department See Alcohol and Tobacco Tax and Trade Bureau See Foreign Assets Control Office See Internal Revenue Service Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Declaration of Status of Dependents, 53194 2013-21007 Dental Patient Satisfaction Survey, 53195 2013-20990 Loan Service Report, 53195-53196 2013-21000 Principles of Excellence Complaint System Intake, 53196-53197 2013-20957 Request for Disinterment, 53197-53198 2013-20903 State Cemetery Data, 53194-53195 2013-20988 Statement of Heirs for Payment of Credits Due Estate of Deceased Veteran, 53196 2013-20902 Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 53200-53216 2013-20984 Part III Interior Department, Fish and Wildlife Service, 53218-53229 2013-20981 Part IV Presidential Documents, 53231-53236 2013-21189 2013-21188 Reader Aids Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 78 167 Wednesday, August 28, 2013 Rules and Regulations DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 310 [Docket No. FSIS-2012-0038] Changes to the Salmonella Verification Sampling Program: Analysis of Raw Beef for Shiga Toxin-Producin Escherichia coli and Salmonella AGENCY:
Food Safety and Inspection Service, USDA. ACTION: Request for comments. SUMMARY: The Food Safety and Inspection Service
(FSIS)is announcing changes to its procedures for *Salmonella* verification sampling program of raw beef products. On the date that FSIS will announce in the **Federal Register** document that responds to any comments on this document, FSIS will discontinue *Salmonella* sampling set procedures (“HC01”) in ground beef products, except in establishments with results that exceeded the standard for *Salmonella* in that establishment's most recently completed sample set (i.e., in those establishments in Category 3). At the same time, FSIS will begin analyzing for *Salmonella* all raw beef samples that it collects for Shiga toxin-producing *Escherichia coli*
(STEC)analysis. Therefore, FSIS will begin analyzing for *Salmonella* all samples of raw ground beef, beef manufacturing trimmings, bench trim, and other raw ground beef components that it collects for STEC testing. To be consistent with the Agency's STEC analytic sample portions, FSIS laboratories will increase the raw ground beef analytic sample portion for *Salmonella* analysis from 25 grams to 325 grams. This notice describes how FSIS intends to use the results from its verification sampling program to develop new *Salmonella* performance standards for ground beef product and to estimate *Salmonella* prevalence in raw ground beef and beef manufacturing trimmings products. Finally, this document discusses changes that the Agency is considering related to FSIS *Salmonella* sampling and testing of other products. DATES: Submit comments on or before September 27, 2013. Interested parties need to get their comments in on time because the Agency does not intend to grant any extensions of the comment period. ADDRESSES: FSIS invites interested persons to submit comments on this document. Comments may be submitted by one 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, Food Safety and Inspection Service, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163B, Washington, DC 20250-3700. *Hand- or courier-delivered submittals:* Deliver to Patriots Plaza 3, 355 E. Street SW., Room 8-163B, Washington, DC 20250-3700. *Instructions:* All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2012-0038. 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 to comments received, go to the FSIS Docket Room at Patriots Plaza 3, 355 E. Street SW., Room 164, Washington, DC 20250-3700 between 8 a.m. and 4:30 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development; Telephone:
(202)205-0495; or by Fax:
(202)720-2025. SUPPLEMENTARY INFORMATION: FSIS administers a regulatory program under the Federal Meat Inspection Act
(FMIA)(21 U.S.C. 601 et seq.) that is intended to ensure that meat and meat food products distributed in commerce are wholesome; not adulterated; and properly marked, labeled, and packaged. As part of its inspection program, FSIS collects samples of these products for laboratory analysis (21 U.S.C. 642(a)). History of the Salmonella Verification Sampling Program The *Salmonella* verification sampling program formally began with the Agency's final rule, entitled “Pathogen Reduction; Hazard Analysis and Critical Control Point (PR/HACCP) Systems,” which FSIS published on July 25, 1996 (61 FR 38805-38989; *http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf).* Among other things, the PR/HACCP rule set *Salmonella* performance standards for establishments producing selected classes of raw meat products, including ground beef, steers and heifers, and cows and bulls (9 CFR 310.25(b)). In 2011, FSIS stopped sampling and testing for *Salmonella* in steers and heifers and cows and bulls because percent positive findings were very low (less than one percent), and this carcass sampling was expensive for the Agency. As stated in the PR/HACCP rule (at 61 FR 38835), FSIS selected *Salmonella* for the performance standard because it is the most common cause of foodborne illness associated with meat and poultry products; it is present to varying degrees in all major species; and the interventions targeted at reducing *Salmonella* may help reduce contamination by other enteric pathogens. FSIS uses the *Salmonella* performance standards to verify process control in slaughter and certain processing operations. The performance standard for ground beef is based on the industry average (percent positive samples) estimated from baseline surveys conducted before PR/HACCP was implemented. Under the existing *Salmonella* verification sampling program, the Agency assesses whether establishments meet the *Salmonella* standard by collecting randomly selected product samples using the risk-based, 3-category establishment classification system announced on February 27, 2006 (71 FR 9772). FSIS inspection program personnel collect samples and submit them to FSIS laboratories for analysis over a defined number of sequential days of production to complete a sample set. As detailed in the February 2006 notice, the maximum number of positive samples per set for the ground beef product category is 5 of 53. FSIS presently categorizes establishment performance as follows: I. Category 1. Consistent Process Control: Establishments with percent positive Salmonella samples at 50 percent or less of the performance standard in the two most recently completed sample sets. II. Category 2T. Variable Process Control but Transitioning Towards Consistent Process Control: Establishments with percent positive Salmonella samples at 50 percent or less of the performance standard in the most recently completed sample set, but greater than 50 percent of the performance standard in the previously completed sample set. III. Category 2. Variable Process Control: Establishments with percent positive Salmonella samples above 50 percent but not exceeding the standard in the most recently completed sample set. IV. Category 3. Highly Variable Process Control: Establishments with percent positive Salmonella samples exceeding the performance standard in the most recently completed sample set. FSIS collects ground beef samples under project code “HC01” as part of the *Salmonella* verification sampling program and under project code “MT43” as part of the *E. coli* O157:H7 verification sampling program. Following the implementation of PR/HACCP, FSIS analyzed only one pathogen per sample. Then, in 2008, FSIS began analyzing for *Salmonella* and *E. coli* O157:H7 ground beef samples from establishments producing less than 1,000 pounds of product per day (under the MT43S code). Using this approach, FSIS effectively gained sampling efficiencies without overly burdening the establishment with additional sample collection. Public Health Concerns *Salmonella* bacteria are among the most frequently reported causes of foodborne illness. In December 2011, a multi-state outbreak linked to a multi-drug resistant strain of *Salmonella* sickened 19 people in the Northeast United States ( *http://www.cdc.gov/salmonella/typhimurium-groundbeef/010512/index.html* ). In June 2012, FSIS was notified of a cluster of *Salmonella enteriditis* illnesses linked to ground beef consumption with approximately 50 case-patients across nine states ( *http://www.cdc.gov/salmonella/enteritidis-07-12/index.html* ). The outbreaks referenced here and others suggest that *Salmonella* in ground beef is a continuing public health concern. The changes described below will likely improve FSIS's ability to detect *Salmonella* by increasing the raw ground beef analytic sample portion for *Salmonella* analysis and increasing the number of establishments being sampled at any given time. ** As is also discussed below, FSIS intends to develop new performance standards that will likely lead establishments producing ground beef to strengthen their own *Salmonella* control measures. Such changes at establishments will likely have a positive impact on public health. Changes to Salmonella Verification Sampling Programs for Raw Ground Beef Products Beginning on the date FSIS will announce in the **Federal Register** notice that responds to any comments on this notice, FSIS will discontinue *Salmonella* sampling sets (“HC01”) for ground beef product except for establishments in Category 3. At the same time, FSIS will begin analyzing for *Salmonella* all raw beef samples it collects for STEC testing. Therefore, FSIS will begin analyzing for *Salmonella* all samples of raw ground beef, beef manufacturing trimmings, bench trim, and other raw ground beef components that its personnel collect for STEC testing, including raw ground beef products FSIS samples at retail stores and ground beef, trim, and other raw ground beef components FSIS samples at import establishments. Whenever FSIS finds a product sample positive for *E. coli* O157:H7 or a non-O157 STEC, FSIS conducts follow-up sampling of product from the establishment that produced the positive product and at all suppliers that provided the source materials for the product. When FSIS begins analyzing for *Salmonella* the product collected for STEC analysis, FSIS will also begin analyzing for *Salmonella* the follow-up samples it collects in response to STEC positive results. FSIS analyzes beef manufacturing trimmings for *E. coli* O157:H7 and the following non-O157 STECs: O26, O45, O103, O111, O121, and O145. FSIS analyzes raw ground beef and raw ground beef components other than beef manufacturing trimmings for E. coli O157:H7 only. FSIS is not making any changes to the STEC sampling and testing programs at this time. The changes that FSIS is announcing to its *Salmonella* sampling procedures will permit FSIS to analyze more samples at the same time for lower Agency costs than the present method. Also, as noted above, FSIS stopped testing beef carcasses for *Salmonella* because the Agency sampling costs did not justify the results FSIS was able to obtain. Through this new approach, FSIS will be able to analyze for *Salmonella* beef manufacturing trimmings and other raw ground beef components at slaughter establishments. FSIS believes sampling these products will provide FSIS more information about *Salmonella* at these establishments than FSIS was able to gather through carcass testing. FSIS will increase the raw ground beef analytic portion for *Salmonella* analysis from 25 grams to 325 grams to be consistent with the STEC analytic sample portions. To support an increase in the sample size analyzed, FSIS evaluated the FSIS *Salmonella* detection method (FSIS Microbiology Laboratory Guidebook Chapter 4.06) using 325 gram samples. Based on this analysis, FSIS expects the increase in the analytical portion size to have at least the same, but likely more of a positive, impact on public health because the likelihood of detecting positive samples increases with the analytical portion size. As is explained above, FSIS will continue to schedule sets for raw ground beef in those establishments in Category 3. FSIS laboratories will continue to evaluate raw ground beef product samples collected as part of a set using a 25-gram analytic sample portion. FSIS intends to enumerate samples that confirm *Salmonella* -positive using the Most Probable Number
(MPN)quantitative procedure. FSIS will continue to evaluate *Salmonella* isolates from the screen-positive samples for multi-drug resistance, to serotype the samples, and to use pulsed-field gel electrophoresis
(PFGE)to identify specific strains of *Salmonella.* Through this analysis, FSIS will determine whether Agency-positive *Salmonella* results are associated with illnesses or serotypes of human health significance. As is currently the case, if FSIS finds that establishments have produced product associated with illness, FSIS will typically conduct an Incident Investigation Team Review or Food Safety Assessment at the establishment. Estimating Prevalence In developing all of its prevalence estimates, FSIS defines prevalence as the proportion of applicable product that would test positive for a given pathogen if the entire population were sampled and analyzed during a specified time period. Although it provides a useful indication of process control within that establishment, set-based verification sampling that FSIS currently uses for *Salmonella* sampling and testing in many products is not designed to estimate national prevalence of *Salmonella* by class of products. As is discussed above, under the set-based approach, FSIS collects samples from the same establishment on a daily basis until it has collected the necessary number of samples in the applicable performance standard. In 2012, FSIS evaluated many of its sampling programs as a means to calculate prevalence estimates for pathogens in FSIS-regulated products ( *http://www.fsis.usda.gov/wps/wcm/connect/56b2ccbd-ad57-4311-b6df-289822d28115/Prevalence_Estimates_Report.pdf?MOD=AJPERES* ). The Agency concluded, given the construction of the FSIS pathogen verification sampling programs at that time, that it was only possible to utilize the *E. coli* O157:H7 pathogen verification testing program for raw ground beef (“MT43”) to estimate national prevalence. Since that time, FSIS has redesigned its beef manufacturing trimmings verification sampling program such that, with a larger number of analyzed samples, it too is suitable for estimating prevalence ( *http://www.fsis.usda.gov/wps/wcm/connect/15e75329-978f-43f0-b8fe-101845d898f0/Redesign_Beef_Trim_Sampling_Methodology.pdf?MOD=AJPERES* ). When FSIS begins analyzing all STEC samples for *Salmonella,* FSIS will be able to estimate the prevalence of *Salmonella* in raw ground beef and beef manufacturing trimmings. Therefore, FSIS will avoid the added expense of conducting separate baseline studies at periodic intervals to determine *Salmonella* prevalence in these products and will enhance the use of inspection resources. In addition, by using these continuous sampling programs rather than scheduled sets, FSIS will be able to analyze findings over time to determine trends and evaluate program effectiveness. Because of the limited number of available samples scheduled and collected, FSIS does not believe it is possible to estimate prevalence for *Salmonella* in raw ground beef components other than beef manufacturing trimmings (such as bench trim). New Performance Standards After collecting at least three months of data using the new sampling and testing procedures, FSIS intends to conduct a risk assessment and develop a revised *Salmonella* performance standard for raw ground beef at a 325 gram sample size. FSIS will publish the revised *Salmonella* performance standard in the **Federal Register** before implementing the standard. In 2011, FSIS estimated the national prevalence of *Salmonella* in beef manufacturing trimmings ( *http://www.fsis.usda.gov/wps/wcm/connect/f07f5e1d-63f2-4ec8-a83a-e1661307b2c3/Baseline_Data_Domestic_Beef_Trimmings_Rev.pdf?MOD=AJPERES* ). After careful consideration, FSIS does not believe the low incidence of *Salmonella* on beef manufacturing trimmings supports development of a *Salmonella* performance standard for beef manufacturing trimmings. FSIS is considering using the results of this estimation to develop guidance that will assist establishments in preventing *Salmonella* contamination in beef manufacturing trimmings. FSIS recently revised other existing *Salmonella* performance standards to achieve a public health objective. In July 2011, FSIS implemented new performance standards for both *Salmonella* and *Campylobacter* for chilled carcasses in young chicken (broilers) and turkey slaughter establishments (76 FR 15282; March 21, 2011). By December 2011, the young chicken industry was meeting the acceptable *Campylobacter* percent positive reflected in the new standard at 9.43 percent (10.4 percent acceptable). Should FSIS develop new *Salmonella* performance standards for ground beef, FSIS believes that ground beef establishments would improve process control to meet the new performance standard in a similar manner. Except for Category 3 establishments, FSIS will discontinue set testing at least until it establishes a revised *Salmonella* performance standard for ground beef. Meanwhile, FSIS is considering alternative sampling plans. One option that FSIS is considering is a “moving window” sampling plan in which FSIS would evaluate a set number of sequential results from single establishment to assess process control. For example, if FSIS chose to evaluate 20 results under the moving window approach, FSIS would assess the most recent 20 FSIS results for a particular establishment. This new approach would allow for on-going scheduled FSIS *Salmonella* sampling, similar to the approach FSIS uses for STEC testing, as compared to a set-based approach in which FSIS schedules a large number of sequential samples at an establishment as part of a set. The “moving window” approach would provide FSIS with more flexibility for scheduling sample collection at different establishments. The Agency requests comment on the “moving window” approach. Other Sampling Procedures Consistent with current sampling procedures, when an establishment either processes all raw ground beef product into ready-to-eat
(RTE)product or moves it to another federally-inspected establishment for further processing into RTE product, the product will be excluded from Agency verification sampling for *E. coli* O157:H7 and *Salmonella.* Individual sample results generated from this program will be reported through the Agency's Public Health Information System. FSIS will ensure that result information is made available to establishments. Because FSIS does not recognize *Salmonella* as a pathogen that would ordinarily render the product injurious to health, and thus as an adulterant within the meaning of 21 U.S.C. 601(m)(1), individual *Salmonella* sample results will not result in regulatory control actions. Therefore, after receiving STEC (O157:H7 and non-O157) results, establishments will not need to continue to hold product that has tested negative for STEC. If raw, non-intact beef product or raw, intact beef product that is intended for use as raw, non-intact product tests positive for STEC, the product is adulterated within the meaning of 21 U.S.C. 601(m)(1) (76 FR 58157; Sep. 20, 2011) unless further processed to destroy the pathogen. Other Changes Under Consideration In addition to ground beef, FSIS is considering moving *Salmonella* sampling from a set-based approach to a continuous sampling and “moving window” approach for all classes of products subject to FSIS sampling and testing for *Salmonella.* As is discussed above, this approach will allow FSIS more flexibility in scheduling and collecting samples. In addition, FSIS is considering implementing new sampling of product classes not subject to FSIS sampling and testing for *Salmonella.* For example, FSIS is contemplating initiating sampling and testing for *Salmonella* in pork trim, pork parts, ground pork, chicken parts, and lamb carcasses. Before FSIS makes any change of this type in its testing, it will provide notice and an opportunity for comment in the **Federal Register** . Should FSIS decide to start testing new products for *Salmonella,* it would begin by sampling to assess the prevalence of *Salmonella* in each of the new products sampled. Upon completion of the exploratory sampling period (at least three months and possibly longer), FSIS would develop new performance standards. FSIS would announce the tentative standards in the **Federal Register** and request comment on them before finalizing. USDA Nondiscrimination Statement The U.S. Department of Agriculture
(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, audiotape, etc.) 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. Additional Public Notification FSIS will announce this notice online through the FSIS Web page located at *http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register* . 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/wps/portal/fsis/programs-and-services/email-subscription-service* . 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 at Washington, DC on: August 16, 2013. Alfred V. Almanza, Administrator. [FR Doc. 2013-20995 Filed 8-27-13; 8:45 am]
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- 9 CFR 310
- 9 CFR 310.25(b)
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