Rules and Regulations Federal Register Vol

39895

Rules and Regulations Federal Register Vol. 77, No. 130

Friday, July 6, 2012

This section of the FEDERAL REGISTER online instructions at that site for of Health and Human Services are the contains regulatory documents having general submitting comments. Federal agencies primarily involved in applicability and legal effect, most of which Mail, including floppy disks or CD– managing this program. EPA and FDA are keyed to and codified in the Code of ROMs, and hand-or courier-delivered have statutory authority to establish Federal Regulations, which is published under items: Send to U.S. Department of residue tolerances through regulations 50 titles pursuant to 44 U.S.C. 1510. Agriculture (USDA), FSIS, Docket Clerk, that limit the quantity of a chemical for The Code of Federal Regulations is sold by Patriots Plaza 3, 1400 Independence the protection of public health. FDA, the Superintendent of Documents. Prices of Avenue SW., Room 8–163A, Mailstop under the Federal Food, Drug, and new books are listed in the first FEDERAL 3782, Washington, DC 20250–3700. Cosmetic Act, establishes tolerances or REGISTER issue of each week. Instructions: All items submitted by action levels for veterinary drugs, food mail or electronic mail must include the additives, and environmental Agency name and docket number FSIS– contaminants. EPA, under the Federal DEPARTMENT OF AGRICULTURE 2011–0012. Comments received in Insecticide, Fungicide and Rodenticide response to this docket will be made Act (as modified by the Food Quality Food Safety and Inspection Service available for public inspection and Protection Act), establishes tolerance posted without change, including any levels for registered pesticides. Title 21 9 CFR Parts 417 personal information, to http:// CFR sets out tolerance levels established [Docket No. FSIS–2012–0012] www.regulations.gov. by FDA; Title 40 CFR sets out tolerance Docket: For access to background levels established by EPA. New Analytic Methods and Sampling documents or to comments received, go The NRP is designed to provide a Procedures for the United States to the FSIS Docket Room at the address structured process for identifying and National Residue Program for Meat, listed above between 8:30 a.m. and 4:30 evaluating chemical compounds of Poultry, and Egg Products p.m., Monday through Friday. concern in food animals; collecting, AGENCY: Food Safety and Inspection FOR FURTHER INFORMATION CONTACT: For analyzing and reporting results; and Service, USDA. information: Contact Rachel Edelstein, identifying the need for regulatory ACTION: Notice. Deputy Assistant Administrator, Office follow-up when violative levels of of Policy and Program Development, at chemical residues are found. The NRP SUMMARY: The Food Safety and (202) 720–0399, or by fax at (202) 720– tests for the presence of chemical Inspection Service (FSIS) is announcing 2025. compounds, including approved (legal) that it is restructuring the United States SUPPLEMENTARY INFORMATION: and unapproved (illegal) veterinary National Residue Program (NRP) with drugs, pesticides, hormones, and respect to how sampling of chemical I. Background environmental contaminants that may compounds and animal production and FSIS administers a regulatory program appear in meat, poultry, and egg egg product classes is scheduled. To under the Federal Meat Inspection Act products. complement this new approach to (FMIA) (21 U.S.C. 601 et seq.), the A scheduled residue sampling sampling and scheduling, the Agency is Poultry Products Inspection Act (PPIA) program is developed annually by implementing several multi-residue (21 U.S.C. 453 et seq.), and the Egg representatives from FSIS, FDA, EPA, methods for analyzing samples of meat, Products Inspection Act (21 U.S.C. 1031 and other Federal agencies, including poultry, and egg products for animal et seq.) to protect the health and welfare the USDA Agricultural Research Service drug residues, pesticides, and of consumers by regulating the meat, (ARS) and Agricultural Marketing environmental contaminants in its poultry, and egg products produced in Service (AMS) and the Centers for inspector-generated testing program. federally inspected establishments. Disease Control and Prevention (CDC). These modern, high-efficiency methods Through its inspections, the Agency These agencies meet at least once a year will conserve resources and provide endeavors to prevent the distribution in as part of the Surveillance Advisory useful and reliable results while commerce of any such products that are Team (SAT). The SAT creates the enabling FSIS to analyze each sample adulterated or misbranded, thereby annual sampling plan (per calendar for more chemical compounds than was reducing the risk of foodborne illness year) using sample results from the previously possible. from FSIS-regulated products. One way NRP, information that the agencies have DATES: New methods and procedures in which the Agency effects its accumulated during investigations, and will be effective 30 days from regulatory program is through the information from veterinary drug publication of this notice. United States National Residue Program inventories that FDA has compiled ADDRESSES: FSIS invites interested (NRP). The NRP is designed to protect during on-farm visits. The agencies persons to submit comments on this the public from exposure to harmful create a list of chemical compounds for document. Comments may be submitted levels of chemical residues in meat, testing and rank them using by either of the following methods: poultry, and egg products produced or mathematical equations that include Federal eRulemaking Portal: This imported into the United States. The variables for public health risk and Web site provides the ability to type NRP requires the cooperation and regulatory concern. In addition to short comments directly into the collaboration of several agencies for establishing a relative ranking for the comment field on this Web page or successful design and implementation. chemicals, the SAT determines the attach a file for lengthier comments. Go FSIS, the Environmental Protection compound/production class pairs of to Regulations.Gov at http:// Agency (EPA), and the Food and Drug public health concern and evaluates www.regulations.gov/ and follow the Administration (FDA) of the Department FSIS laboratory capacity and analytical

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methods to devise a final sampling plan. hazards. FSIS will take regulatory action collected samples from each production FSIS publishes the final sampling plan against an establishment that does not class, the new FSIS program will rotate in the National Residue Program have an adequate chemical residue production classes through Tier 1. Sampling Plan, which is traditionally control program in place. Where FSIS has allocated a maximum of referred to as the Blue Book. 300 samples per chemical compound NRP Operating Structure Since 1967, FSIS has administered the class in the traditional program, the new NRP by collecting samples from meat, In practice, the NRP consists of three structure will allocate approximately poultry, and egg products and analyzing separate but interrelated chemical 800 samples per chemical compound the samples at one of three FSIS residue testing programs: Scheduled class for each of the production classes laboratories. A basis for concern appears sampling, inspector-generated sampling, tested in Tier 1. when an FSIS laboratory detects a and import sampling. This basic Under Tier 1 during CY 2012 chemical compound level in excess of structure has been in existence since domestic scheduled sampling program, an established tolerance or action level 1967, though modified over the years to FSIS will run 6,400 samples through 12 in a sample. FSIS shares laboratory adjust to emerging and reemerging multi-residue methods across nine findings that exceed established chemical residue concerns and to production classes of meat and poultry, tolerances and action levels with FDA improvements in testing methodologies. which represent 95 percent of the meat and EPA. If the findings are for Under the current scheduled and poultry consumed domestically. imported product, FSIS shares them sampling program, FSIS calculates the Eliminating the ‘‘paired sampling’’ with the competent authority in the number of samples needed for the protocol will result in more samples run foreign country from where the product scheduled sampling as part of a ‘‘paired per production class and more analytes originated. FDA has jurisdiction on- sampling’’ protocol. Since the 2006 targeted. Samples from Tier 1 will be farm, and FSIS assists FDA in obtaining residue program, FSIS has sampled 230 analyzed at either the FSIS Eastern or the names of producers and other or 300 animals for each chemical Western laboratories. parties involved in offering the animals compound/production class pair. For New Scheduled Sampling Program Tier for sale. FSIS informs producers through instance, if FSIS scheduled heifers to be 2 certified letters when an animal from tested for four different chemical their business has a violative level of a compound classes (for example, The new Tier 2 will resemble the residue. FDA and cooperating State antibiotics, chlorinated hydrocarbons, b- traditional inspector-generated sampling agencies investigate producers linked to agonists, and sulfonamides), FSIS program at the establishment level. The residue violations. If a problem is not inspectors would collect approximately inspector-generated program is a corrected, subsequent FDA visits could three hundred samples for each of the targeted testing program in which field result in an enforcement action, chemical compound classes. Therefore, public health veterinarians make the including prosecution. FSIS inspectors would collect samples determination to perform in-plant At the request of industry, FSIS posts from approximately 1,200 heifers (300 screens on carcasses because they a weekly list of repeat residue violators. samples by four chemical compound suspect that animals or carcasses The Residue Repeat Violators List classes = 1,200 samples collected). contain higher than allowable levels of includes producers associated with Applying sampling rates of 230 or 300 chemical residues. Samples from more than one violation on a rolling 12- in food animals and egg products carcasses having positive in-plant month basis. Because FSIS updates this assures FSIS a 90 percent and 95 screens are sent to the FSIS Midwestern list weekly, FDA may not have percent probability, respectively, of Laboratory for confirmation, and the investigated each violation. The list detecting chemical residue violations if carcass is held pending results. In 2010, provides helpful information to the violation rate is equal to or greater field personnel completed more than processors and producers who are than one percent. For the Calendar Year 200,000 in-plant screens resulting in working to avoid illegal levels of (CY) 2011 domestic scheduled sampling almost 7,000 positive samples submitted residues, serves to deter violators, and program, FSIS laboratories completed to the FSIS Midwestern Laboratory for enables FSIS and FDA to make better 21,555 analyses across multiple confirmation. FSIS implemented the use of their resources. production classes and chemicals. newest in-plant screen (Kidney TM Recognizing that a scientifically Several of the analytical methods tested Inhibition Swab (KIS ) test) in 2009, sound chemical residue prevention for multiple compounds. and since then, the Midwestern program is essential to encourage the Laboratory has instituted a policy of prudent use of pesticides and veterinary New NRP Structure repeating the KISTM test on positive in- drugs in food animals, in the late 1990s During CY 2012, in contrast, FSIS is plant KISTM screens received from the FSIS implemented the Hazard Analysis significantly modifying the scheduled field. In 2012, FSIS will begin using a and Critical Control Points (HACCP) sampling approach by eliminating the multi-analytic screening method inspection system in all federally ‘‘paired sampling’’ protocol. FSIS will discussed below on inspector-generated inspected meat and poultry be analyzing fewer samples but by using in-plant screen positives submitted to establishments to verify that, among multi-residue methods will actually be the Midwestern Laboratory. other things, the establishments have assessing more compounds per sample. Simultaneously, FSIS will effective residue controls in their food As part of this new approach, FSIS is discontinue the use of the 7-plate production systems. In pertinent part, establishing three tiers of sampling for bioassay in the Midwestern Laboratory the HACCP regulations (9 CFR Part 417) the NRP. as a primary screen for field positive require that FSIS-inspected slaughter samples. Inspector-generated samples establishments identify all food safety Tier 1—New Scheduled Sampling will be tested using the updated multi- hazards, including drug residues, Program residue analytic screening method on pesticide residues, and chemical The new Tier 1 resembles the current in-plant samples described below in the contaminants, that are reasonably likely scheduled sampling program and section on New Methodology. Because to occur before, during, and after entry should be understood as an exposure the multi-analytic method is into the establishment and establish assessment. Where the current significantly superior to the KISTM test, preventive measures to control these scheduled sampling program has it will be unnecessary to repeat the

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KISTM test on field-screen positive Tier 3 will provide a vehicle for This notice announces the adoption samples submitted to the Midwestern developing information that will by FSIS of a new screening method for Laboratory. Hence, the turnaround time support future policy development antibiotics and environmental for availability of regulatory results will within the NRP. FSIS is evaluating contaminants. The current official FSIS be reduced. implementation issues and screening methodology for antibiotics is FSIS will continue, however, to use requirements for Tier 3 activities. a 7-plate bioassay. The 7-plate bioassay the bioassay for quantification of those screen has several drawbacks: (1) It only Import Sampling veterinary drugs having tolerances works for microbial growth-inhibiting associated with the bioassay as required The import-sampling program will be residues (certain antibiotics within and by FDA New Animal Drug Applications structured using the Tier 1 and 2 among classes); (2) it is not sensitive (NADA). frameworks. In CY 2012, FSIS intends to enough for sulfonamides and The new Tier 2 also will absorb the collect approximately 1300 import fluoroquinolones in relation to their traditional exploratory assessment samples—500 samples under Tier 1 and tolerances, but it is much too sensitive program at the production class and 800 samples under Tier 2. It also as a screen for tetracyclines and certain compound class level. Exploratory intends to screen a subset of these aminoglycosides with high tolerances; assessments are targeted sampling plans samples for unknown compounds in the (3) it does not distinguish one drug from designed, for example, in response to FSIS Food Emergency Response another in the same class; (4) the results information gained from previous Network (FERN) laboratory. can be difficult to interpret, especially when multiple drugs are present; (5) it exposure assessments and intelligence New Methodology and Sampling is prone to unknown microbial from other agencies. Consequently, FSIS Procedures may use the data results from Tier 1 inhibition responses; (6) it takes a team sampling to inform the type of sampling The analytical methods that have of personnel to set up the assay and that will occur in Tier 2. been used for many years in the NRP to more than 16 hours to obtain the results; measure veterinary drug residues in and (7) the measurement uncertainty New Scheduled Sampling Program meat, poultry, and egg products are associated with the 7-plate bioassay is Tier 3 laborious, expensive, and time large compared with other methods. FSIS is further planning a Tier 3 level, consuming and, as a result, sometimes The new multi-residue method which the Agency anticipates will be prevent the timely testing of food (MRM) being implemented by FSIS similar in structure to the exploratory products before they are released into provides significant improvements: (1) assessment program in Tier 2, with the the marketplace. More modern, It can screen for a variety of analytes, exception that Tier 3 will encompass performance-based analytical methods not just antibiotics; (2) the method can targeted testing at the herd or flock can reduce cost, increase the number of be validated at levels appropriate in level. FSIS anticipates that certain analytes that can be measured, and relation to tolerances; (3) because of the chemical exposures may occur that improve precision and accuracy while power of mass spectrometry, it can involve more than one animal or bird. also shortening turn-around time. clearly distinguish individual analytes, For instance, producers may administer Modern methods use multi-residue even if multiple drugs are present in the some veterinary drugs to a herd or a techniques to quantify a larger number same sample; (4) unknown microbial flock (for example, growth promotants of analytes with greater precision inhibition responses would be or antibiotics given in the feed) in a way (repeatability) and accuracy (degree of mitigated; and (5) the time and that involves misuse. In addition, closeness to actual value). Such personnel needed to obtain results is livestock and birds may be exposed methods can often be performed with reduced. unintentially to an environmental faster throughput and at lower cost than The 52 analytes shown in the contaminant. Therefore, a targeted conventional single residue methods. In following table are appropriate for testing program designed for livestock the food regulation arena, improved inclusion in the new MRM at and above or flocks originating from the same farm analytical methods are necessary if the level specified. Analytes that were or region may be necessary on occasion regulatory agencies are to effectively not analyzed during the 2011 NRP to determine the level of a chemical or monitor for the increasing number of sampling plan and had not been chemicals to which the livestock or the chemical residues and to protect public included for testing in previous years birds in the flock have been exposed. health. are in italics.

ANALYTES AND APPLICABILITY LEVEL [(μ g/g) for MRM]

7-plate Analyte Bovine kidney Porcine kidney 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 ......

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ANALYTES AND APPLICABILITY LEVEL—Continued [(μ g/g) for MRM]

7-plate Analyte Bovine kidney Porcine kidney bioassay (ppm)

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 equipment for the Eastern and Western As stated above, under the new methods, approximately 6,400 samples Laboratories is anticipated to cost system approximately 6,400 samples of of two pounds of muscle and one pound $250,000 per instrument, resulting in a two pounds of muscle and one pound each of kidney and liver will be total cost in the second year of each of kidney and liver will be collected, in contrast to approximately implementation of $550,000 for two collected, in contrast to approximately 20,000 samples collected per year under instruments and service maintenance. 20,000 samples collected per year under the current system in which the Agency (Maintenance of the 2 instruments is at the current system in which the Agency collects one pound each of muscle, the rate of 10 percent of the cost of each collects one pound each of muscle, kidney, and liver. Although FSIS instrument.) FSIS is exploring the kidney, and liver. The muscle samples inspectors will be collecting more possibility of leasing this equipment, will be larger, but the total number of muscle with every sample, they will be which would significantly reduce the samples collected will be much smaller. collecting far fewer samples. startup cost and eliminate the The smaller number of samples required Cost-Benefit Analysis maintenance cost. The annualized cost will result in cost savings to FSIS that of the instruments plus maintenance will be realized through reductions in The new methodologies will result in over 6 years at 7 percent equals special delivery shipments and in additional costs for the Agency only for approximately $112,000 and, if inspector time spent collecting samples. the purchase and maintenance of new discounted at 3 percent, equals about At approximately $20 a shipment, a equipment that will enable the FSIS $108,000. The Agency does not expect reduction of approximately 13,600 laboratories to use the new multi- a significant impact on other laboratory samples that will not need to be residue method. Equipment for the resources because of the instrument collected will equal approximately Midwestern Laboratory was replaced purchases. In sum, FSIS sees only a $272,000 saved annually. At and charged under the old program. The small cost to the taxpayer in approximately 30 minutes allowed for additional purchase of the same implementing the new methodology. an inspector to collect and package a

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sample, the savings for 13,600 samples Impact on Foreign and State to be included. The Update is also will equal approximately $218,280. Stakeholders available on the FSIS Web page. In Thus, given annualized costs of The proposed plan remains addition, FSIS offers an electronic mail approximately $112,000 (7 percent) or statistically structured relative to subscription service which provides $108,000 (3 percent) and annual sample collection of imported products. automatic and customized access to recurring benefits of $490,280, net FSIS and other federal agencies will selected food safety news and annual benefits exceed the costs by continue to select chemicals tested information. This service is available at http://www.fsis.usda.gov/ approximately $378,280. within the U.S. program using a risk- _ _ _ based approach. FSIS expects countries News & Events/Email Subscription/. Benefits to the public health are likely Options range from recalls to export to occur because the Agency will be able exporting meat, poultry, and egg products to the United States to control information to regulations, directives to test for more residues with the and notices. Customers can add or additional new methods, but those chemical residues in the products that they export. FSIS will continue to delete subscriptions themselves, and benefits cannot be quantified at this have the option to password protect time. require foreign countries to maintain equivalent residue control programs (9 their accounts. Impact on Small Entities CFR 327.2(a)(2)(iv)(C)). Therefore, FSIS Done at Washington, DC, on June 29, 2012. does not anticipate any trade issues or Alfred V. Almanza, The new sampling program will international consequences. Administrator. operate according to a scheduling States that administer ‘‘at least equal algorithm that will ensure that [FR Doc. 2012–16571 Filed 7–5–12; 8:45 am] to’’ cooperative State meat or poultry BILLING CODE 3410–DM–P establishments are sampled in inspection (MPI) programs need to proportion to their production volume, complete and sign an ‘‘Annual and the Agency expects no negative Statement of Defensible Laboratory NUCLEAR REGULATORY impact on small businesses. Because of Results’’ as part of their annual ‘‘at least COMMISSION the design of the algorithm used for the equal to’’ self-assessment. States under new sampling program, small the Cooperative Interstate Shipment 10 CFR Chapter I businesses may be sampled less Program must demonstrate that their frequently than is the case under the laboratory services used to analyze [NRC–2012–0092] current system. This differential in regulatory samples are capable of RIN 3150–AJ16 frequency of sampling is likely to offset producing results that are the ‘‘same as’’ any economic losses conceivably those obtained by FSIS laboratories. Technical Corrections resulting from the increased size of an Requirements for demonstrating ‘‘same individual sample. as’’ status can be found at http:// AGENCY: Nuclear Regulatory Expected Changes in Violation Rates askfsis.custhelp.com/app/answers/ Commission. detail/a_id/1622/related/1. State ACTION: Final rule. The nine classes to be sampled for CY laboratories operating under the 2012 under the new program are Cooperative Interstate Shipment SUMMARY: The U.S. Nuclear Regulatory specified as Bob Veal, Beef Cows, Dairy Program need to use the protocols for Commission (NRC or the Commission) Cows, Steers, Heifers, Market Swine, analytical tests required for FSIS is amending its regulations to make Sows, Young Chicken, and Young regulatory activities on meat and technical corrections, including Turkey. The number of samples taken poultry and egg products described in updating the street address for its for nine species classes for CY 2012 will the FSIS Chemistry, Microbiological, Region I office, correcting authority be 800 per class except for steers and and Pathology Laboratory Guidebooks. citations and typographical and spelling heifers, which have 400 each. The total The authorities of affected States should errors, and making other edits and allocation per species class and the take note of the methodological conforming changes. This document is number of samples allocated per species developments described in this notice. necessary to inform the public of these class may change, as will the species non-substantive changes to the NRC’s classes sampled in successive years. Additional Public Notification regulations. Assuming a constant rate of violations FSIS will announce this document DATES: This rule is effective August 6, estimated from those in CY 2011, the online through the FSIS Web page 2012. number of expected violations will tend located at http://www.fsis.usda.gov/ to increase in some but not all cases regulations_&_policies/ FOR FURTHER INFORMATION CONTACT: even though the total number of Federal_Register_Notices/index.asp. Jennifer Borges, Rules, Announcements, samples will decrease. This is because FSIS will also make copies of this and Directives Branch, Division of the number of analyses run per sample Federal Register publication available Administrative Services, Office of will be increased in CY 2012 compared through the FSIS Constituent Update, Administration, U.S. Nuclear Regulatory to CY 2011. Specifically, based on which is used to provide information Commission, Washington, DC 20555– historical data on chemical residue regarding FSIS policies, procedures, 0001, telephone: 301–492–3675, email: violations, the Agency expects that Bob regulations, Federal Register notices, [email protected]. Veal, Beef Cows, and Sows may show FSIS public meetings, and other types of ADDRESSES: Please refer to Docket ID some increase in violations, while Dairy information that could affect or would NRC–2012–0092 when contacting the Cows, Steers, Heifers, Market Swine, be of interest to constituents and NRC about the availability of Young Chicken, and Young Turkey may stakeholders. The Update is information for this final rule. You may show no change in violations. The total communicated via Listserv, a free access information and comment net increase in violations expected is electronic mail subscription service for submittals related to this final unlikely to have a significant impact industry, trade groups, consumer rulemaking, which the NRC possesses because the residue violative rate is very interest groups, health professionals, and are publicly available, by any of the low. and other individuals who have asked following methods:

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