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--- schema: federal-register doc_type: fedreg source_file: FR-2012-07-06.xml --- 77 130 Friday, July 6, 2012 Contents Agriculture Agriculture Department See Food Safety and Inspection Service See Forest Service See Risk Management Agency Antitrust Division Antitrust Division NOTICES National Cooperative Research and Production Act of 1993: American Gap Association, 40085 2012-16507 Connected Media Experience, Inc., 40086 2012-16510 FDI Cooperation LLC, 40085-40086 2012-16509 Petroleum Environmental Research Forum, 40086 2012-16511 Antitrust See Antitrust Division Army Army Department See Engineers Corps NOTICES Meetings:
Army Science Board Summer Study, 40030 2012-16544 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40061-40068 2012-16508 2012-16514 2012-16526 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 39990 2012-16530 Commodity Futures Commodity Futures Trading Commission NOTICES Meetings;
Sunshine Act, 40023 2012-16706 Corporation Corporation for National and Community Service NOTICES Meetings; Sunshine Act, 40023 2012-16693 Defense Department Defense Department See Army Department See Engineers Corps NOTICES Arms Sales, 40023-40030 2012-16554 2012-16555 2012-16556 Drug Drug Enforcement Administration NOTICES Importers of Controlled Substances; Applications: Cerilliant Corp., 40087 2012-16502 Chattem Chemicals Inc., 40086-40087 2012-16501 Education Department Education Department NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Race to the Top Annual Performance Report, 40031 2012-16579 Energy Department Energy Department See Federal Energy Regulatory Commission NOTICES Meetings: Methane Hydrate Advisory Committee, 40032 2012-16550 Engineers Engineers Corps NOTICES Environmental Impact Statements; Availability, etc.: Sierra Vista Specific Plan Project, City of Roseville, Placer County, CA, 40030-40031 2012-16545 Environmental Protection Environmental Protection Agency RULES Approval, Disapproval and Promulgation of Implementation Plans:
Nebraska; Regional Haze State Implementation Plan; Federal Implementation Plan for Best Available Retrofit Technology Determination, 40150-40169 2012-15192 Approvals and Promulgations of Air Quality Implementation Plans: Illinois; Regional Haze, 39943-39948 2012-16557 Maryland; Regional Haze State Implementation Plan, 39938-39943 2012-16417 Effective Date for the Water Quality Standards for Florida's Lakes and Flowing Waters, 39949-39952 2012-16421 PROPOSED RULES Data Call-in Orders for Pesticide Tolerances:
Difenzoquat, 39962-39965 2012-16295 Draft Guidance to Implement Requirements: Treatment of Air Quality Monitoring Data Influenced by Exceptional Events, 39959-39962 2012-16308 NOTICES Certain New Chemicals; Receipt and Status Information, 40033-40036 2012-16453 Environmental Impact Statements; Availability, etc., 40036-40037 2012-16576 Meetings: Draft Report, An Assessment of Potential Mining Impacts on Salmon Ecosystems of Bristol Bay, AK, 40037-40039 2012-16441 Receipts of Requests to Voluntarily Cancel Certain Pesticide Registrations, 40039-40048 2012-16448 Registration Reviews;
Pesticide Dockets, 40048-40051 2012-16328 Federal Aviation Federal Aviation Administration RULES New York North Shore Helicopter Route, 39911-39921 2012-16667 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 40051 2012-16650 Federal Energy Federal Energy Regulatory Commission NOTICES Complaints: Alison Haverty v. Potomac-Appalachian Transmission Highline, LLC, 40032 2012-16561 Initiation of Proceedings and Refund Effective Date: Maine Public Service Co., 40032 2012-16562 Federal Financial Federal Financial Institutions Examination Council NOTICES Meetings:
Appraisal Subcommittee, 40051 2012-16560 2012-16563 Federal Highway Federal Highway Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40141-40142 2012-15923 Federal Motor Federal Motor Carrier Safety Administration NOTICES Applications for Exemption: Commercial Driver's License and Hours-of-Service of Drivers, 40142-40144 2012-16549 Federal Railroad Federal Railroad Administration NOTICES Environmental Impact Statements; Availability, etc.:
East Side Access Project, 40144-40146 2012-16669 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40051-40058 2012-16484 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 40058-40059 2012-16483 Fiscal Fiscal Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: ACH Vendor/Miscellaneous Payment Enrollment Form, 40148 2012-16408 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants:
Listing the Hyacinth Macaw, 39965-39983 2012-16461 Listing the Scarlet Macaw, 40222-40247 2012-16445 Two Foreign Macaw Species, 40172-40219 2012-16492 Migratory Bird Hunting: Application for Approval of Fluoropolymeric Shot Coatings as Nontoxic for Waterfowl Hunting, 39983 2012-16543 Food and Drug Food and Drug Administration RULES Changes in Specifications: D and C Red No. 6 and D and C Red No. 7, 39921-39923 2012-16581 Effective Date of Requirement for Premarket Approval: Cardiovascular Permanent Pacemaker Electrode, 39924-39927 2012-16486 PROPOSED RULES Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses;
Effective Date, 39953-39959 2012-16487 NOTICES Draft Guidance for Industry: Donor Questioning, Deferral, Reentry, etc. to Reduce Risk of Transfusion-Transmitted Malaria, 40068-40069 2012-16528 Enforcement Action Dates: Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use, 40069-40072 2012-16475 Program Assessment for Enhanced Review Transparency and Communication: New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act, 40072-40073 2012-16529 Food Safety Food Safety and Inspection Service RULES New Analytic Methods and Sampling Procedures for the United States National Residue Program for Meat, Poultry, and Egg Products, 39895-39899 2012-16571 Forest Forest Service NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Forest Industries and Residential Fuelwood and Post Data Collection Systems, 39985-39986 2012-16504 Health Screening Questionnaire, 39986-39987 2012-16505 Recreation Administration Permit and Fee Envelope, 39984-39985 2012-16503 Environmental Impact Statements; Availability, etc.: Arapaho and Roosevelt National Forests and Pawnee National Grassland; Boulder and Gilpin County, CO, 39987-39988 2012-16300 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration NOTICES Designations of Classes of Employees for Addition to Special Exposure Cohort:
Feed Materials Production Center, Fernald, OH, 40059 2012-16591 Findings of Research Misconduct, 40059-40060 2012-16572 Renewal of Declaration Regarding Emergency Use of All Oral Formulations of Doxycycline, etc., 40060-40061 2012-16588 Homeland Homeland Security Department See U.S. Citizenship and Immigration Services See U.S. Customs and Border Protection Housing Housing and Urban Development Department NOTICES Federal Properties Suitable as Facilities to Assist Homeless, 40078-40079 2012-16459 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Ocean Energy Management Bureau See Surface Mining Reclamation and Enforcement Office International Trade Adm International Trade Administration NOTICES Antidumping Duty Administrative Reviews;
Results, Extensions, Amendments, etc.: Certain Polyester Staple Fiber from People's Republic of China, 39990-39996 2012-16586 Applications for Duty-Free Entry of Scientific Instruments: Department of Mechanical Engineering, Texas A and M University; Decision, 39996-39997 2012-16582 Consolidated Decisions on Applications for Duty-Free Entry of Electron Microscope: University of Connecticut, et al., 39997 2012-16585 Court Decision Not in Harmony and Amended Final Results: Heavy Forged Hand Tools, Finished or Unfinished, With or Without Handles from the People's Republic of China, 39997-39998 2012-16575 International Trade Com International Trade Commission NOTICES Investigations;
Terminations, Modifications and Rulings: Certain Gaming and Entertainment Consoles, Related Software, and Components Thereof, 40082-40083 2012-16482 Certain Personal Data and Mobile Communications Devices and Related Software, 40083-40084 2012-16574 Certain Portable Communication Devices, 40084 2012-16485 Justice Department Justice Department See Antitrust Division See Drug Enforcement Administration NOTICES Lodgings of Modifications of Consent Decrees: Clean Water Act, 40084-40085 2012-16495 Labor Department Labor Department See Occupational Safety and Health Administration Land Land Management Bureau NOTICES Environmental Impact Statements;
Availability, etc.: Hycroft Mine Expansion, Humboldt and Pershing Counties, NV, 40079-40080 2012-16565 Maritime Maritime Administration NOTICES Requests for Administrative Waivers of the Coastwise Trade Laws: Vessel Satisfaction , 40146-40147 2012-16418 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 40073-40076 2012-16500 Meetings: National Institute of Environmental Health Sciences, 40076 2012-16497 Prospective Grants of Exclusive Licenses:
Use of Citrus Flavanones Hesperetin, Hesperidin, and Naringenin in Nutrition for Endothelial Function, etc., 40076-40077 2012-16499 National Oceanic National Oceanic and Atmospheric Administration NOTICES Meetings: Gulf of Mexico Fishery Management Council, 39998-39999 2012-16553 Mid-Atlantic Fishery Management Council, 39998 2012-16533 Permits: Marine Mammals; File No. 17278, 39999 2012-16580 Takes of Marine Mammals Incidental to Specified Activities: Marine Seismic Survey in Beaufort Sea, AK, 40007-40023 2012-16584 Pile Placement for Fishermen's Offshore Wind Farm, 39999-40006 2012-16583 National Park National Park Service RULES Vehicles and Traffic Safety;
Bicycles, 39927-39938 2012-16466 NOTICES Schedule of Fees for Reviewing Historic Preservation Certification Applications; Correction, 40080 2012-16278 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Biological Sciences Proposal Classification Form, 40090 2012-16537 Meetings; Sunshine Act, 40090-40091 2012-16567 Nuclear Regulatory Nuclear Regulatory Commission RULES Technical Corrections, 39899-39911 2012-16176 NOTICES Environmental Impact Statements;
Availability, etc.: Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating, Units 2 and 3, 40091-40092 2012-16548 License Amendments: Increase in Maximum Reactor Power Level, Florida Power and Light Co., St. Lucie, Units 1 and 2, 40092-40106 2012-16552 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 1,3 Butadiene Standard, 40087-40088 2012-16512 Permanent Variances;
Technical Amendments, Revocations: Rollins College; T.A. Loving Co., US Ecology Idaho, Inc., and West Pharmaceutical Services, Inc., 40088-40090 2012-16513 Ocean Energy Management Ocean Energy Management Bureau NOTICES Final Programmatic Environmental Impact Statement: Proposed Final Five-Year Outer Continental Shelf Oil and Gas Leasing Program for 2012-2017, 40080-40081 2012-16152 Gulf of Mexico, Outer Continental Shelf, Western and Central Planning Areas: Oil and Gas Lease Sales for 2012-2017, 40081 2012-16149 Public Debt Public Debt Bureau See Fiscal Service Risk Risk Management Agency NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 39988-39990 2012-16564 Securities Securities and Exchange Commission NOTICES Applications for Deregistration under the Investment Company Act, 40106-40107 2012-16547 Orders of Suspension of Trading: A-Power Energy Generation Systems, Ltd., 40107 2012-16654 Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., 40109-40110 2012-16516 BOX Options Exchange, LLC, 40123-40124 2012-16542 C2 Options Exchange, Inc., 40118-40120 2012-16569 Chicago Board Options Exchange, Inc., 40120-40121 2012-16568 International Securities Exchange, LLC, 40121-40123, 40136-40139 2012-16520 2012-16546 NASDAQ OMX BX, Inc., 40125 2012-16541 NASDAQ OMX Phlx, LLC, 40126-40127 2012-16540 NASDAQ Stock Market LLC, 40127-40129 2012-16539 New York Stock Exchange LLC, 40133-40136 2012-16521 NYSE Amex LLC, 40139-40140 2012-16518 NYSE Arca, Inc., 40110-40112 2012-16517 NYSE MKT LLC, 40107-40109, 40112-40118, 40129-40132 2012-16515 2012-16519 2012-16522 State Department State Department NOTICES Statutory Debarments:
Pratt and Whitney Canada Corp., 40140-40141 2012-16578 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40077 2012-16558 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40081-40082 2012-16489 Surface Transportation Surface Transportation Board NOTICES Abandonment Exemptions:
Boston and Maine Corp., Worcester County, MA, 40147 2012-16577 Pan Am Southern, LLC. in Worcester County, MA, 40147-40148 2012-16573 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration See Maritime Administration See Surface Transportation Board Treasury Treasury Department See Fiscal Service U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Petition for Qualifying Family Member of U-1 Nonimmigrant; Correction, 40077-40078 2012-16494 Customs U.S. Customs and Border Protection NOTICES Approvals as Commercial Gaugers: Inspectorate America Corp., 40078 2012-16534 Separate Parts In This Issue Part II Environmental Protection Agency, 40150-40169 2012-15192 Part III Interior Department, Fish and Wildlife Service, 40172-40219 2012-16492 Part IV Interior Department, Fish and Wildlife Service, 40222-40247 2012-16445 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. 77 130 Friday, July 6, 2012 Rules and Regulations DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 417 [Docket No. FSIS-2012-0012] New Analytic Methods and Sampling Procedures for the United States National Residue Program for Meat, Poultry, and Egg Products AGENCY:
Food Safety and Inspection Service, USDA. ACTION: Notice. SUMMARY: The Food Safety and Inspection Service
(FSIS)is announcing that it is restructuring the United States National Residue Program
(NRP)with respect to how sampling of chemical compounds and animal production and egg product classes is scheduled. To complement this new approach to sampling and scheduling, the Agency is implementing several multi-residue methods for analyzing samples of meat, poultry, and egg products for animal drug residues, pesticides, and environmental contaminants in its inspector-generated testing program. These modern, high-efficiency methods will conserve resources and provide useful and reliable results while enabling FSIS to analyze each sample for more chemical compounds than was previously possible. DATES: New methods and procedures will be effective 30 days from publication of this notice. ADDRESSES: FSIS invites interested persons to submit comments on this document. 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 Regulations.Gov at *http://www.regulations.gov/* and 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 U.S. Department of Agriculture (USDA), FSIS, Docket Clerk, Patriots Plaza 3, 1400 Independence Avenue SW., Room 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 *http://www.regulations.gov.* *Docket:* For access to background documents or to comments received, go to the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: For information: Contact Rachel Edelstein, Deputy Assistant Administrator, Office of Policy and Program Development, at
(202)720-0399, or by fax at
(202)720-2025. SUPPLEMENTARY INFORMATION: I. Background FSIS administers a regulatory program under the Federal Meat Inspection Act
(FMIA)(21 U.S.C. 601 *et seq.* ), the Poultry Products Inspection Act
(PPIA)(21 U.S.C. 453 *et seq.* ), and the Egg Products Inspection Act (21 U.S.C. 1031 *et seq.* ) to protect the health and welfare of consumers by regulating the meat, poultry, and egg products produced in federally inspected establishments. Through its inspections, the Agency endeavors to prevent the distribution in commerce of any such products that are adulterated or misbranded, thereby reducing the risk of foodborne illness from FSIS-regulated products. One way in which the Agency effects its regulatory program is through the United States National Residue Program (NRP). The NRP is designed to protect the public from exposure to harmful levels of chemical residues in meat, poultry, and egg products produced or imported into the United States. The NRP requires the cooperation and collaboration of several agencies for successful design and implementation. FSIS, the Environmental Protection Agency (EPA), and the Food and Drug Administration
(FDA)of the Department of Health and Human Services are the Federal agencies primarily involved in managing this program. EPA and FDA have statutory authority to establish residue tolerances through regulations that limit the quantity of a chemical for the protection of public health. FDA, under the Federal Food, Drug, and Cosmetic Act, establishes tolerances or action levels for veterinary drugs, food additives, and environmental contaminants. EPA, under the Federal Insecticide, Fungicide and Rodenticide Act (as modified by the Food Quality Protection Act), establishes tolerance levels for registered pesticides. Title 21 CFR sets out tolerance levels established by FDA; Title 40 CFR sets out tolerance levels established by EPA. The NRP is designed to provide a structured process for identifying and evaluating chemical compounds of concern in food animals; collecting, analyzing and reporting results; and identifying the need for regulatory follow-up when violative levels of chemical residues are found. The NRP tests for the presence of chemical compounds, including approved (legal) and unapproved (illegal) veterinary drugs, pesticides, hormones, and environmental contaminants that may appear in meat, poultry, and egg products. A scheduled residue sampling program is developed annually by representatives from FSIS, FDA, EPA, and other Federal agencies, including the USDA Agricultural Research Service
(ARS)and Agricultural Marketing Service
(AMS)and the Centers for Disease Control and Prevention (CDC). These agencies meet at least once a year as part of the Surveillance Advisory Team (SAT). The SAT creates the annual sampling plan (per calendar year) using sample results from the NRP, information that the agencies have accumulated during investigations, and information from veterinary drug inventories that FDA has compiled during on-farm visits. The agencies create a list of chemical compounds for testing and rank them using mathematical equations that include variables for public health risk and regulatory concern. In addition to establishing a relative ranking for the chemicals, the SAT determines the compound/production class pairs of public health concern and evaluates FSIS laboratory capacity and analytical methods to devise a final sampling plan. FSIS publishes the final sampling plan in the *National Residue Program Sampling Plan,* which is traditionally referred to as the Blue Book. Since 1967, FSIS has administered the NRP by collecting samples from meat, poultry, and egg products and analyzing the samples at one of three FSIS laboratories. A basis for concern appears when an FSIS laboratory detects a chemical compound level in excess of an established tolerance or action level in a sample. FSIS shares laboratory findings that exceed established tolerances and action levels with FDA and EPA. If the findings are for imported product, FSIS shares them with the competent authority in the foreign country from where the product originated. FDA has jurisdiction on-farm, and FSIS assists FDA in obtaining the names of producers and other parties involved in offering the animals for sale. FSIS informs producers through certified letters when an animal from their business has a violative level of a residue. FDA and cooperating State agencies investigate producers linked to residue violations. If a problem is not corrected, subsequent FDA visits could result in an enforcement action, including prosecution. At the request of industry, FSIS posts a weekly list of repeat residue violators. The Residue Repeat Violators List includes producers associated with more than one violation on a rolling 12-month basis. Because FSIS updates this list weekly, FDA may not have investigated each violation. The list provides helpful information to processors and producers who are working to avoid illegal levels of residues, serves to deter violators, and enables FSIS and FDA to make better use of their resources. Recognizing that a scientifically sound chemical residue prevention program is essential to encourage the prudent use of pesticides and veterinary drugs in food animals, in the late 1990s FSIS implemented the Hazard Analysis and Critical Control Points (HACCP) inspection system in all federally inspected meat and poultry establishments to verify that, among other things, the establishments have effective residue controls in their food production systems. In pertinent part, the HACCP regulations (9 CFR Part 417) require that FSIS-inspected slaughter establishments identify all food safety hazards, including drug residues, pesticide residues, and chemical contaminants, that are reasonably likely to occur before, during, and after entry into the establishment and establish preventive measures to control these hazards. FSIS will take regulatory action against an establishment that does not have an adequate chemical residue control program in place. NRP Operating Structure In practice, the NRP consists of three separate but interrelated chemical residue testing programs: Scheduled sampling, inspector-generated sampling, and import sampling. This basic structure has been in existence since 1967, though modified over the years to adjust to emerging and reemerging chemical residue concerns and to improvements in testing methodologies. Under the current scheduled sampling program, FSIS calculates the number of samples needed for the scheduled sampling as part of a “paired sampling” protocol. Since the 2006 residue program, FSIS has sampled 230 or 300 animals for each chemical compound/production class pair. For instance, if FSIS scheduled heifers to be tested for four different chemical compound classes (for example, antibiotics, chlorinated hydrocarbons, β-agonists, and sulfonamides), FSIS inspectors would collect approximately three hundred samples for each of the chemical compound classes. Therefore, FSIS inspectors would collect samples from approximately 1,200 heifers (300 samples by four chemical compound classes = 1,200 samples collected). Applying sampling rates of 230 or 300 in food animals and egg products assures FSIS a 90 percent and 95 percent probability, respectively, of detecting chemical residue violations if the violation rate is equal to or greater than one percent. For the Calendar Year
(CY)2011 domestic scheduled sampling program, FSIS laboratories completed 21,555 analyses across multiple production classes and chemicals. Several of the analytical methods tested for multiple compounds. New NRP Structure During CY 2012, in contrast, FSIS is significantly modifying the scheduled sampling approach by eliminating the “paired sampling” protocol. FSIS will be analyzing fewer samples but by using multi-residue methods will actually be assessing more compounds per sample. As part of this new approach, FSIS is establishing three tiers of sampling for the NRP. Tier 1—New Scheduled Sampling Program The new Tier 1 resembles the current scheduled sampling program and should be understood as an exposure assessment. Where the current scheduled sampling program has collected samples from each production class, the new FSIS program will rotate production classes through Tier 1. Where FSIS has allocated a maximum of 300 samples per chemical compound class in the traditional program, the new structure will allocate approximately 800 samples per chemical compound class for each of the production classes tested in Tier 1. Under Tier 1 during CY 2012 domestic scheduled sampling program, FSIS will run 6,400 samples through 12 multi-residue methods across nine production classes of meat and poultry, which represent 95 percent of the meat and poultry consumed domestically. Eliminating the “paired sampling” protocol will result in more samples run per production class and more analytes targeted. Samples from Tier 1 will be analyzed at either the FSIS Eastern or Western laboratories. New Scheduled Sampling Program Tier 2 The new Tier 2 will resemble the traditional inspector-generated sampling program at the establishment level. The inspector-generated program is a targeted testing program in which field public health veterinarians make the determination to perform in-plant screens on carcasses because they suspect that animals or carcasses contain higher than allowable levels of chemical residues. Samples from carcasses having positive in-plant screens are sent to the FSIS Midwestern Laboratory for confirmation, and the carcass is held pending results. In 2010, field personnel completed more than 200,000 in-plant screens resulting in almost 7,000 positive samples submitted to the FSIS Midwestern Laboratory for confirmation. FSIS implemented the newest in-plant screen (Kidney Inhibition Swab (KIS TM ) test) in 2009, and since then, the Midwestern Laboratory has instituted a policy of repeating the KIS TM test on positive in-plant KIS TM screens received from the field. In 2012, FSIS will begin using a multi-analytic screening method discussed below on inspector-generated in-plant screen positives submitted to the Midwestern Laboratory. Simultaneously, FSIS will discontinue the use of the 7-plate bioassay in the Midwestern Laboratory as a primary screen for field positive samples. Inspector-generated samples will be tested using the updated multi-residue analytic screening method on in-plant samples described below in the section on New Methodology. Because the multi-analytic method is significantly superior to the KIS TM test, it will be unnecessary to repeat the KIS TM test on field-screen positive samples submitted to the Midwestern Laboratory. Hence, the turnaround time for availability of regulatory results will be reduced. FSIS will continue, however, to use the bioassay for quantification of those veterinary drugs having tolerances associated with the bioassay as required by FDA New Animal Drug Applications (NADA). The new Tier 2 also will absorb the traditional exploratory assessment program at the production class and compound class level. Exploratory assessments are targeted sampling plans designed, for example, in response to information gained from previous exposure assessments and intelligence from other agencies. Consequently, FSIS may use the data results from Tier 1 sampling to inform the type of sampling that will occur in Tier 2. New Scheduled Sampling Program Tier 3 FSIS is further planning a Tier 3 level, which the Agency anticipates will be similar in structure to the exploratory assessment program in Tier 2, with the exception that Tier 3 will encompass targeted testing at the herd or flock level. FSIS anticipates that certain chemical exposures may occur that involve more than one animal or bird. For instance, producers may administer some veterinary drugs to a herd or a flock (for example, growth promotants or antibiotics given in the feed) in a way that involves misuse. In addition, livestock and birds may be exposed unintentially to an environmental contaminant. Therefore, a targeted testing program designed for livestock or flocks originating from the same farm or region may be necessary on occasion to determine the level of a chemical or chemicals to which the livestock or the birds in the flock have been exposed. Tier 3 will provide a vehicle for developing information that will support future policy development within the NRP. FSIS is evaluating implementation issues and requirements for Tier 3 activities. Import Sampling The import-sampling program will be structured using the Tier 1 and 2 frameworks. In CY 2012, FSIS intends to collect approximately 1300 import samples—500 samples under Tier 1 and 800 samples under Tier 2. It also intends to screen a subset of these samples for unknown compounds in the FSIS Food Emergency Response Network
(FERN)laboratory. New Methodology and Sampling Procedures The analytical methods that have been used for many years in the NRP to measure veterinary drug residues in meat, poultry, and egg products are laborious, expensive, and time consuming and, as a result, sometimes prevent the timely testing of food products before they are released into the marketplace. More modern, performance-based analytical methods can reduce cost, increase the number of analytes that can be measured, and improve precision and accuracy while also shortening turn-around time. Modern methods use multi-residue techniques to quantify a larger number of analytes with greater precision (repeatability) and accuracy (degree of closeness to actual value). Such methods can often be performed with faster throughput and at lower cost than conventional single residue methods. In the food regulation arena, improved analytical methods are necessary if regulatory agencies are to effectively monitor for the increasing number of chemical residues and to protect public health. This notice announces the adoption by FSIS of a new screening method for antibiotics and environmental contaminants. The current official FSIS screening methodology for antibiotics is a 7-plate bioassay. The 7-plate bioassay screen has several drawbacks:
(1)It only works for microbial growth-inhibiting residues (certain antibiotics within and among classes);
(2)it is not sensitive enough for sulfonamides and fluoroquinolones in relation to their tolerances, but it is much too sensitive as a screen for tetracyclines and certain aminoglycosides with high tolerances;
(3)it does not distinguish one drug from another in the same class;
(4)the results can be difficult to interpret, especially when multiple drugs are present;
(5)it is prone to unknown microbial inhibition responses;
(6)it takes a team of personnel to set up the assay and more than 16 hours to obtain the results; and
(7)the measurement uncertainty associated with the 7-plate bioassay is large compared with other methods. The new multi-residue method
(MRM)being implemented by FSIS provides significant improvements:
(1)It can screen for a variety of analytes, not just antibiotics;
(2)the method can be validated at levels appropriate in relation to tolerances;
(3)because of the power of mass spectrometry, it can clearly distinguish individual analytes, even if multiple drugs are present in the same sample;
(4)unknown microbial inhibition responses would be mitigated; and
(5)the time and personnel needed to obtain results is reduced. The 52 analytes shown in the following table are appropriate for inclusion in the new MRM at and above the level specified. Analytes that were not analyzed during the 2011 NRP sampling plan and had not been included for testing in previous years are in italics. Analytes and Applicability Level [(μ g/g) for MRM] Analyte Bovine kidney Porcine kidney 7-plate bioassay
(ppm)Ampicillin 0.02 0.02 0.05 Beta-dexamethasone 0.05 0.05 Cefazolin 0.2 0.2 Chloramphenicol 0.006 0.006 20 Chlortetracycline 1 1 0.05 Cimaterol 0.012 0.003 Ciprofloxacin 0.025 0.025 Clindamycin 0.05 0.05 Cloxacillin 0.02 0.02 1.6 Danofloxacin 0.025 0.025 DCCD (marker for Ceftiofur) 0.2 0.2 Desthylene Ciprofloxacin 0.025 0.025 Dicloxacillin 0.2 0.2 Difloxacin 0.025 0.025 Enrofloxacin 0.025 0.025 Erythromycin A 0.05 0.05 0.25 Florfenicol 0.1 0.1 Florfenicol Amine * 0.15 Flunixin 0.0125 0.0125 Gamithromycin 0.05 0.05 Lincomycin 0.05 0.05 1.5 Nafcillin 0.2 0.2 Norfloxacin 0.025 0.025 Oxacillin 0.2 0.2 Oxyphenylbutazone * 0.05 Oxytetracycline 0.5 0.5 0.4 Penicillin G 0.1 0.1 0.05 Phenylbutazone * 0.05 Pirlimycin 0.25 0.25 Prednisone 0.05 0.05 Ractopamine 0.003 0.003 Salbutamol 0.006 0.003 Sarafloxacin 0.025 0.025 Sulfachloropyridizine 0.05 0.05 Sulfadiazine 0.05 0.05 Sulfadimethoxine 0.05 0.05 Sulfadoxine 0.05 0.05 Sulfaethoxypyridazine 0.05 0.05 Sulfamerazine 0.05 0.05 Sulamethazine 0.05 0.05 150 Sulfamethizole 0.05 0.05 Sulfamethoxazole 0.05 0.05 Sulfamethoxypyridazine 0.05 0.05 Sulfanilamide * 0.1 Sulfanitran 0.05 0.05 Sulfapyridine 0.05 0.05 Sulfaquinoxaline 0.05 0.05 Sulfathiazole 0.05 0.05 Tetracycline 0.5 0.5 0.4 Tilmicosin 0.12 0.24 0.5 Tylosin 0.1 0.2 1 Zearalanol * 0.012 * This analyte is not applicable for bovine kidney in the MRM. With the new sampling and analytic methods, approximately 6,400 samples of two pounds of muscle and one pound each of kidney and liver will be collected, in contrast to approximately 20,000 samples collected per year under the current system in which the Agency collects one pound each of muscle, kidney, and liver. Although FSIS inspectors will be collecting more muscle with every sample, they will be collecting far fewer samples. Cost-Benefit Analysis The new methodologies will result in additional costs for the Agency only for the purchase and maintenance of new equipment that will enable the FSIS laboratories to use the new multi-residue method. Equipment for the Midwestern Laboratory was replaced and charged under the old program. The additional purchase of the same equipment for the Eastern and Western Laboratories is anticipated to cost $250,000 per instrument, resulting in a total cost in the second year of implementation of $550,000 for two instruments and service maintenance. (Maintenance of the 2 instruments is at the rate of 10 percent of the cost of each instrument.) FSIS is exploring the possibility of leasing this equipment, which would significantly reduce the startup cost and eliminate the maintenance cost. The annualized cost of the instruments plus maintenance over 6 years at 7 percent equals approximately $112,000 and, if discounted at 3 percent, equals about $108,000. The Agency does not expect a significant impact on other laboratory resources because of the instrument purchases. In sum, FSIS sees only a small cost to the taxpayer in implementing the new methodology. As stated above, under the new system approximately 6,400 samples of two pounds of muscle and one pound each of kidney and liver will be collected, in contrast to approximately 20,000 samples collected per year under the current system in which the Agency collects one pound each of muscle, kidney, and liver. The muscle samples will be larger, but the total number of samples collected will be much smaller. The smaller number of samples required will result in cost savings to FSIS that will be realized through reductions in special delivery shipments and in inspector time spent collecting samples. At approximately $20 a shipment, a reduction of approximately 13,600 samples that will not need to be collected will equal approximately $272,000 saved annually. At approximately 30 minutes allowed for an inspector to collect and package a sample, the savings for 13,600 samples will equal approximately $218,280. Thus, given annualized costs of approximately $112,000 (7 percent) or $108,000 (3 percent) and annual recurring benefits of $490,280, net annual benefits exceed the costs by approximately $378,280. Benefits to the public health are likely to occur because the Agency will be able to test for more residues with the additional new methods, but those benefits cannot be quantified at this time. Impact on Small Entities The new sampling program will operate according to a scheduling algorithm that will ensure that establishments are sampled in proportion to their production volume, and the Agency expects no negative impact on small businesses. Because of the design of the algorithm used for the new sampling program, small businesses may be sampled less frequently than is the case under the current system. This differential in frequency of sampling is likely to offset any economic losses conceivably resulting from the increased size of an individual sample. Expected Changes in Violation Rates The nine classes to be sampled for CY 2012 under the new program are specified as Bob Veal, Beef Cows, Dairy Cows, Steers, Heifers, Market Swine, Sows, Young Chicken, and Young Turkey. The number of samples taken for nine species classes for CY 2012 will be 800 per class except for steers and heifers, which have 400 each. The total allocation per species class and the number of samples allocated per species class may change, as will the species classes sampled in successive years. Assuming a constant rate of violations estimated from those in CY 2011, the number of expected violations will tend to increase in some but not all cases even though the total number of samples will decrease. This is because the number of analyses run per sample will be increased in CY 2012 compared to CY 2011. Specifically, based on historical data on chemical residue violations, the Agency expects that Bob Veal, Beef Cows, and Sows may show some increase in violations, while Dairy Cows, Steers, Heifers, Market Swine, Young Chicken, and Young Turkey may show no change in violations. The total net increase in violations expected is unlikely to have a significant impact because the residue violative rate is very low. Impact on Foreign and State Stakeholders The proposed plan remains statistically structured relative to sample collection of imported products. FSIS and other federal agencies will continue to select chemicals tested within the U.S. program using a risk-based approach. FSIS expects countries exporting meat, poultry, and egg products to the United States to control chemical residues in the products that they export. FSIS will continue to require foreign countries to maintain equivalent residue control programs (9 CFR 327.2(a)(2)(iv)(C)). Therefore, FSIS does not anticipate any trade issues or international consequences. States that administer “at least equal to” cooperative State meat or poultry inspection
(MPI)programs need to complete and sign an “Annual Statement of Defensible Laboratory Results” as part of their annual “at least equal to” self-assessment. States under the Cooperative Interstate Shipment Program must demonstrate that their laboratory services used to analyze regulatory samples are capable of producing results that are the “same as” those obtained by FSIS laboratories. Requirements for demonstrating “same as” status can be found at *http://askfsis.custhelp.com/app/answers/detail/a_id/1622/related/1.* State laboratories operating under the Cooperative Interstate Shipment Program need to use the protocols for analytical tests required for FSIS regulatory activities on meat and poultry and egg products described in the FSIS Chemistry, Microbiological, and Pathology Laboratory Guidebooks. The authorities of affected States should take note of the methodological developments described in this notice. Additional Public Notification FSIS will announce this document online through the FSIS Web page located at *http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.* FSIS will also make copies of this **Federal Register** publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, **Federal Register** notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at *http://www.fsis.usda.gov/News_&_Events/Email_Subscription/.* Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. Done at Washington, DC, on June 29, 2012. Alfred V. Almanza, Administrator. [FR Doc. 2012-16571 Filed 7-5-12; 8:45 am]
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- 9 CFR 417
- 9 CFR 327.2(a)(2)(iv)(C)
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