UNITED STATES National Residue Program for Meat, Poultry, and Egg Products 2012 RESIDUE SAMPLE RESULTS United States Department of Agriculture Food Safety and Inspection Service Office of Public Health Science September 2014 1 TABLE OF CONTENTS ACKNOWLEDGEMENTS ....................................................................................................................... 5 EXECUTIVE SUMMARY ........................................................................................................................ 7 ACRONYMS ............................................................................................................................................... 9 INTRODUCTION..................................................................................................................................... 11 OVERVIEW Of SAMPLING PLANS .................................................................................................... 15 Domestic Sampling Plan ....................................................................................................... 15 Import Reinspection Sampling Plan ...................................................................................... 17 Table 1. 2012 Estimated Slaughter Data by Production Class ......................................... 18 Table 2. 2012 Imported Meat and Poultry Products by Country ...................................... 19 Definitions of FSIS Production Classes ............................................................................... 20 Figure 1. NRP Domestic Scheduled Samples Flow Chart ................................................. 21 SUMMARY OF DOMESTIC DATA ........................................................................................ 22 Table 3. CY 2012 Number of Samples Tested by Production Class ................................. 22 Chemical Class Information Summary (Pre-August) ........................................................ 23 Domestic Residue Scheduled Sampling ................................................................................. 29 Pre-August ......................................................................................................... 29 Post-August ........................................................................................................ 29 SLAUGHTER CLASS PRE-AUGUST RESULTS. .................................................................................. 30 Table 4. Number of Samples Tested by Production Class.......................................................... 30 Table 5. Beef Cows Summary ................................................................................... 30 Table 6. Bob Veal Summary ..................................................................................... 31 Table 7. Dairy Cows Summary ................................................................................. 31 Table 8. Heifers Summary ......................................................................................... 31 Table 9. Steers Summary ........................................................................................... 32 Table 10. Market Hogs Summary................................................................................ 32 Table 11. Sows Summary ............................................................................................ 32 Table 12. Young Chickens .......................................................................................... 33 Table 13. Young Turkeys ............................................................................................ 33 Table 14 Residue Violations Results (Pre-August) .................................................... 33 2 SLAUGHTER CLASS POST-AUGUST RESULTS. ............................................................................ 34 Table 15. List of Chemical Class-including MRM- associated with slaughter class ................. 34 Table 16. Number of Samples Tested by Production Class (Post-August) ................................ 35 Table 17. Number of Analyses associated with samples tested by Production Class (Post-August) ............................................................................................................................. 35 Table 18 Residue Violations Results (Post-August) ................................................................ 36 Scheduled Sampling — Targeted Assessments .................................................................... 37 Environmental Contaminants (Cadmium and Lead) Table 19. Number of Positive and Non-detect Samples Analyzed for Cadmium and Lead, 2012 Targeted Assessments Results .................................................................................. 37 Table 20. Statistical Analysis of Cadmium and Lead Levels in Kidneys and Muscles from Animal Class, 2012 Targeted Assessments Results .......................................................... 39 2012 NRP Domestic Residue Inspector Generated Sampling................................................. 41 1.Sample Screened In-plant and confirmed in an FSIS Labratory ............................................ 41 Fast Antimicrobial Screen Test (FAST) ............................................................................ 41 Kidney Inhibition Swab (KIS™) Test ............................................................................... 41 2. Sample Confirmed in an FSIS Laboratory.............................................................................. 41 Collector-Generated (COLLGEN) ................................................................................... 41 Show Animals (SHOW) ................................................................................................... 41 State or Government Agency Testing (STATE) ............................................................... 41 Table 21. Summary Results, 2012 Inspector-Generated Sampling by Test Type ........................ 42 Table 22. Summary Violative Residue Animals by Project Name .............................................. 43 Table 23. Distribution of Violative Residue by Production Class and Project Name .................. 44 Table 24. Distribution of Violative Residue by Chemical Residue and Project Name ................ 45 Table 25. Distribution of Violative Residue by Chemical Residue and Animal Class ................ 47 Table 26. Distribution of Non-Violative Positive Residue by Production Class and Project Name ................................................................................................................ 49 Table 27. Distribution of Non-Violative Positive Residue by Chemical Residue and and Project Name ............................................................................................................................................ 50 Table 28. Distribution of Non-Violative Positive Residue by Chemical Residue and Animal Class .............................................................................................................................................. 52 3 2012 NRP Import Residue Results ........................................................................................... 54 Table 29. Number of Samples analyzed by Exporting Countries ................................................. 54 Table 30. Number of Samples analyzed by Exporting Countries and animal Class .................... 55 Table 31. Number of Samples analyzed by Chemical Class ........................................................ 56 Table 32. Number of Samples analyzed by Chemical Class and animal Class ............................ 57 Table 33. Number of Samples analyzed by Chemical Class and Product Type ........................... 57 Appendices ...................................................................................................................................... Appendix I- FSIS Laboratory Analytical Methods ....................................................................... 58 Appendix II- Statistical Table ....................................................................................................... 59 4 ACKNOWLEDGEMENTS The Food Safety and Inspection Service (FSIS) would like to acknowledge and thank the following individuals and groups who helped with the assembly, advice, and review of the United States National Residue Program for Meat, Poultry, and Egg Products 2012 Residue Sample Results. The working group received advice from several people within the Office of Public Health Science (OPHS): Dr. Pat Basu, Senior Advisor – Chemistry, Toxicology and Related Sciences; Dr. Emilio Esteban, Executive Associate for Laboratory Services; Dr. Alice Thaler, Public Health Advisor and FSIS Integrity Officer; Ms. Janell Kause, Scientific Advisor for Risk Assessment; and Dr. Patty Bennett, Deputy Director, Science Staff. Dr. Deep Saini from the Office of Data Integration and Food Protection/Data Analysis and Integration Staff (DAIS) provided technical and data support. 1 FSIS would also like to thank the Agency’s Office of Field Operation’s (OFO) inspection program personnel (IPP) who collected and submitted domestic residue samples. The 2012 sampling and testing program operations were carried out with the support of the OFO district offices located in Alameda, CA; Albany, NY; Atlanta, GA; Beltsville, MD; Chicago, IL; Dallas, TX; Denver, CO; Des Moines, IA; Jackson, MS; Lawrence, KS; Madison, WI; Minneapolis, MN; Philadelphia, PA; Raleigh, NC; and Springdale, AR. 2 FSIS would also like to thank the FSIS import inspection personnel who oversee 116 import facilities at U.S. ports of entry to ensure that imported meat, poultry, and egg products that are sent into U.S. commerce are safe, wholesome, and properly labeled. Additionally, FSIS would like to thank the Agency’s laboratory staff located at the Eastern Laboratory in Athens, GA; the Midwestern Laboratory in St. Louis, MO; the Western Laboratory in Alameda, CA, who prepared and analyzed the residue samples and documented the results, and Laboratory Quality Assurance Staff (LQAS), who coordinated expansion of chemistry methodology in support of the FSIS laboratories. FSIS Field Services Laboratories coordinate and conduct laboratory analytical services in support of the Agency's strategy to maintain food safety in meat, poultry, and egg products along the farm-to-table continuum. 1 In May2013, FSIS implemented an Agency-wide reorganization – the change in titles and staff names reflect the time period post reorganization rather than the structure during this reporting period in 2012. 2 FSIS consolidated 15 field districts into 10 in 2013. 5 FSIS would like to acknowledge the members of the Surveillance Advisory Team (SAT), which includes representatives from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Environmental Protection Agency (EPA), the Animal and Plant Health Inspection Service (APHIS), the Agricultural Marketing Service (AMS), and the Agricultural Research Service (ARS) for their extensive contributions to the United States National Residue Program (NRP). Finally, FSIS would like to thank all of the agencies that submitted feedback and recommendations on enhancing the format and the content of the NRP for meat, poultry, and egg products: residue sample results publication (i.e., the Red Book). CONTACTS AND COMMENTS The USDA/FSIS Office of Public Health Science, Science staff coordinated this effort and is responsible for the publication of this material. Questions about the NRP should be directed to: USDA/FSIS/OPHS/Science Staff 1400 Independence Avenue, SW 355 E Street - Patriot Plaza III Washington, D.C. 20250-3700 Telephone: (202) 690-6409 Fax: (202) 690-6337 E-mail: ChemicalResidue@fsis.usda.gov Web site: http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-andreports/chemistry/residue-chemistry PRINCIPAL AUTHORS (USDA/FSIS/OPHS/Science Staff) Mr. Naser Abdelmajid 6 EXECUTIVE SUMMARY 2012 United States National Residue Program Data The 2012 United States National Residue Program for meat, poultry, and egg products (hereafter the NRP), an interagency chemical testing program administered by the Food Safety and Inspection Service (FSIS), examined food samples for the presence of several different chemical compounds, including veterinary drugs, pesticides, and metals. As described in detail for each chemical compound class within this book, these compounds have been selected because of their potential public health concern. All samples were analyzed at one of three FSIS International Standardization Organization 17025-accredited laboratories: the Eastern Laboratory in Athens, GA; the Midwestern Laboratory in St. Louis, MO; or the Western Laboratory in Alameda, CA. The NRP domestic sampling program comprises scheduled sampling and inspector-generated sampling. This allows the detection of residues or contaminants in food at concentrations that could adversely affect human health. The levels at which violations occur (e.g., those above an established tolerance) are based on toxicological studies evaluating the potential human health risk from exposure to these residues or contaminants. In anticipation of FSIS moving from a sampling system where production classes were paired with single methods to one where a single sample would be analyzed for more than 100 chemicals, FSIS modified the number of samples allocated to the scheduled sampling program. Beginning in January 2012, FSIS reduced the total number of samples from approximately 20,000 to about 6,400 samples, anticipating that the newer methods would enable FSIS to be more effective and efficient. In total, across all NRP sampling programs, FSIS identified 1,199 residue violations in 951 unique animals in CY 2012. Note: A single animal may have multiple tissue violations. Under the domestic scheduled sampling program, FSIS in-plant-personnel (IPP) collected 5,838 residue samples (5,513 from US federal plants, and 325 from US state plants)-, from which 17 residue violations were reported. This number represents 12 unique animal violations, accounting for less than 1 % of samples collected. The drug violations from domestic scheduled samples were mostly antibiotics: Dihydrostreptomycin, Gentamycin Sulfate, Neomycin, Penicillin, Tilmicosin, Sulfamethazine, and Sulfadimethoxine, used to prevent or treat bacterial infections. Generally, drug residue violations result from an inadequate withdrawal time for the drugs to clear the animal’s system. Additionally, the domestic scheduled sampling program identified 26 samples 7 (again, less than 1 %) with non-violative positive residue levels (compared with 155 samples in CY 2011). By definition, a non-violative positive residue sample represents a sample where the residue level is detected below the established tolerance. Under the inspector-generated sampling program, most samples are initially screened in-plant using either the Fast Antimicrobial Screening Test (FAST) kit, or the Kidney Inhibition Swab (KIS™) Test. Samples that screen positive are sent to the FSIS Midwestern Laboratory (ML) for confirmation or in some situations for the initial analysis. For an in-plant screening, the in-plant inspector selects a carcass for sampling based on professional judgment and public health criteria outlined in FSIS Directive 10,800.1, rev 1. From the 214,654 samples screened using either KIS™ or FAST, 5,188 samples (4,967 KIS™, 221 FAST) were submitted to the ML for confirmation. The ML identified 1,166 residue tissue violations in 928 animals (compared with 1,289 residue tissue violations in 1,010 animals in CY 2011). The KIS™ Test screens resulted in the detection of 1,125 violative samples (96% of 1,166) and the FAST screens resulted in the identification of 41 violations (3.5% of 1,166). The remaining 1% of violations were identified through collector-generated samples, samples from show animals, and from the US States testing program. Out of 1,166 violative samples analyzed under the inspector-generated program KIS™ or FAST, Penicillin accounted for the highest percentage of violative samples (270, or 23 %), followed by Neomycin (209, or 18%) and Desfuroylceftiofur Cysteine Disulfide (173, or 15%), compared with Penicillin, Neomycin, and Sulfadimethoxine, respectively in CY 2011. Additionally, the FAST and KIS™ screens under the inspector-generated sampling program identified 1,352 samples with non-violative positive residue levels (compared with 1,810 samples in CY 2011). In addition, FSIS plans and administers an import reinspection program as part of the NRP. After U.S. Customs and Border Protections and USDA/APHIS requirements are met, shipments imported into the United States must be reinspected by FSIS at an approved import inspection facility. FSIS inspectors carry out reinspection in approximately 117 official import plants. Of the 1,299 samples analyzed in 2012, no violations were detected. FSIS continually strives to improve methods for reporting the NRP data. These reports are publicly available on the FSIS website. Interested parties may also contact the OPHS Science Staff at (202) 690-6409 for additional copies of the annual report. 8 ACRONYMS ADRS – Animal Disposition Reporting System AIIS – Automated Import Information System AMDUCA – Animal Medicinal Drug Use Clarification Act AMS – Agricultural Marketing Service APHIS – Animal and Plant Health Inspection Service ARS – Agricultural Research Service CDC – Centers for Disease Control and Prevention CHCs – Chlorinated hydrocarbons COPs – Chlorinated organophosphates COLLGEN – Collector-Generated Samples sent directly to the laboratory CSI - Consumer Safety Inspector DAIS – Data Analysis and Integration Staff DCA – Desfuroylceftiofur Acetamide DCCD – Desfuroylceftiofur Cysteine Disulfide DW – FSIS Data Warehouse FAST – Fast Antimicrobial Screening Test FDA – U.S. Food and Drug Administration FSIS – Food Safety and Inspection Service FRN- Federal Register Notice EPA – U.S. Environmental Protection Agency HACCP – Hazard Analysis and Critical Control Point IPP – Inspection Program Personnel KIS™ Test – Kidney Inhibition Swab Test LQAS - Laboratory Quality Assurance Staff MRM – Multi-class Residue method(s) NASS – National Agricultural Statistics Service 9 ND – Non-detect NRP – National Residue Program NSAID – Non-Steroidal Anti-inflammatory Drug OCIO – Office of the Chief Information Officer OFO – Office of Field Operations OPHS – Office of Public Health Science PBDE – Polybrominated diphenyl ethers PCBs – Polychlorinated biphenyls PHIS – Public Health Information System PHV – Public Health Veterinarian PPB – Parts per billion PPM – Parts per million RVIS – Residue Violation Information System SAT – Surveillance Advisory Team STATE – State or Government Agency Testing SHOW – Show Animals TOI – Type of Inspection UMI – Unidentified Microbial Inhibitor 10 Introduction The U.S. National Residue Program (NRP) for Meat, Poultry, and Egg Products, administered by the USDA- FSIS, is an interagency program designed to identify, rank and test for chemical contaminants in meat, poultry, and egg products. FSIS publishes the NRP’s Residue Sampling Plans (traditionally known as the Blue Book) each year to provide information on the process of sampling meat, poultry, and egg products for chemical contaminants of public health concern. The Blue Book describes the sampling algorithms used to allocate over 6,000 annually scheduled residue samples collected from meat, poultry and egg products and tested for the presence of more than 100 chemical compounds. The NRP requires the cooperation and collaboration of several agencies for its successful design and implementation. The FSIS, the EPA, and the Department of Health and Human Services’ (HHS) FDA are the primary Federal agencies managing this program. The FDA, under the Federal Food, Drug, and Cosmetic Act, establishes tolerances for veterinary drugs, and action levels for food additives and environmental contaminants. The 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 Code of Federal Regulations (CFR) includes tolerance levels established by FDA; Title 40 CFR includes tolerance levels established by EPA. Representatives from FSIS, FDA, EPA, the USDA Agricultural Research Service (ARS), the USDA Agricultural Marketing Service (AMS), and the HHS Centers for Disease Control and Prevention (CDC) collaborate to develop the scheduled sampling program. These agencies work together to create the annual sampling plans using prior NRP findings of chemical compounds in meat, poultry, and egg products, FDA veterinary drug inventories completed during on-farm visits, information from investigations, and pesticides and environmental contaminants of current importance to EPA. The agency representatives convene to identify the residues of public health concern in appropriate production classes, and evaluate FSIS laboratory capacity and analytical methods. FSIS publishes the finalized sampling plans in the annual Blue Book. Chemical compounds tested in the program include approved and unapproved veterinary drugs, pesticides, and environmental compounds. The NRP is designed to: (1) provide a structured process for identifying and evaluating chemical compounds of concern in food animals; (2) analyze chemical compounds of concern; (3) report results; and, (4) identify the need for regulatory follow-up subsequent to the identification of violative levels of chemical residues. FSIS administers this 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 (EPIA) (21 U.S.C. 1031 et seq.). The program is designed to protect the health and welfare of consumers by regulating the meat, poultry, and egg products produced in federally inspected plants and to prevent the distribution in commerce of any such products that are adulterated or misbranded. 11 FSIS has administered the NRP by collecting meat, poultry, and egg product samples and analyzing the samples for specific chemical compounds at FSIS laboratories since 1967 for meat and poultry and since 1995 for egg products. A violation occurs when an FSIS laboratory detects a chemical compound level in excess of an established tolerance or action level, or when a chemical compound without an established tolerance level is detected. FSIS informs the plant via certified letter, and, under best practices, the plant should notify the producer that an animal from that business has a violative chemical level. FSIS also shares the violation data with FDA, which has on-farm jurisdiction, and EPA. FDA and cooperating State agencies investigate producers linked to residue violations, and, if conditions leading to residue violations are not corrected, can enforce legal action. Every week, FSIS posts a Residue Repeat Violator List on its website. The list identifies producers with more than 1 violation on a rolling 12-month basis. In addition, the list provides helpful information to processors and producers who are working to avoid illegal levels of residues, serves as a deterrent for violators, and enables FSIS and FDA to make better use of resources. Because FSIS updates this list weekly, FDA may not have investigated each violation at the time of publication. Transition to New NRP Operating Structure In the late 1990s, FSIS implemented the Hazard Analysis and Critical Control Point (HACCP) inspection system in all federally inspected plants. The HACCP regulation (9 CFR 417) requires FSIS-inspected slaughter and processing plants to identify all food safety hazards (including drug residues, chemical contaminants, pesticides) that are reasonably likely to occur before, during, and after entry of the food animal or product into the plant. The regulation also requires plants to identify preventive measures to control these hazards. FSIS takes regulatory action against plants that do not have an adequate chemical residue control program in place. Minimizing food safety hazards from farm to fork protects consumers from the public health risks associated with chemical contaminants in food. In the past, the sampling program was designed to identify a select number of chemical hazards, primarily veterinary drugs and only a few pesticides and/or heavy metals to see if these chemicals were detected above established tolerances. For the past several years, FSIS sampled 230 or 300 animals for each chemical compound and animal production class pair. Production classes refer to specific animal slaughter classes and broadly include bovine, porcine, caprine, ovine, avian, equine, and other species. Applying these sampling rates ensures FSIS a 90% or 95% probability, respectively, of detecting chemical residue violations if the violation rate is equal to or greater than 1 % in the population being sampled. With increasing public concern about the risks of chemical contaminants, there has been greater focus on strengthening the identification, ranking, and testing for chemical hazards in meat, poultry, and egg products in the U.S. The Calendar Year (CY) 2012 sampling plan for residues in FSISregulated products includes a shift towards a more public health-based sampling approach. This 12 approach includes broader screens for veterinary drugs and pesticides, more analyses for each sample, and the use of performance-based methods. In August 2012, FSIS transitioned to the updated NRP sampling scheme for the remainder of the year, testing nine production classes for more than 100 chemical residues. The transition to using multi-residue analytical methods has eliminated pairing one compound class or individual compound with one production class and allowed FSIS to analyze more compounds per sample while collecting fewer samples. To implement this new approach, FSIS established three tiers of sampling for the NRP. The three-tiered system refers to scheduled sampling (Tier 1), targeted sampling at the production or compound class level (Tier 2), and targeted sampling at the herd/flock or compound class level (Tier 3). Tier 1 includes the current scheduled sampling program. Collection of these data will serve as a baseline level for chemical residue exposure. While FSIS allocated a maximum of 300 samples per chemical compound class in the traditional program, the new structure allocates approximately 800 samples per chemical compound class for each of the production classes tested in Tier 1. By increasing the number of samples taken, FSIS increased the probability of finding a violation to 99% if the violation rate is equal to or greater than 1% in the population being sampled. For Tier 1 within the 2012 domestic scheduled sampling program, FSIS ran thousands of analyses across the nine production classes (beef cows, bob veal, dairy cows, steers, heifers, market hogs, sows, young chickens, and young turkeys) representing 95% of domestic meat and poultry consumption. This change resulted in more analytical results for each production class. Tier 2 includes the traditional inspector-generated sampling program at the plant level. When FSIS Inspection Program Personnel (IPP) detects evidence of disease or use of a drug, they hold and test samples from those carcasses because they might contain violative levels of chemical residues. In CY 2011, IPP completed more than 207,000 in-plant residue screens using the Kidney Inhibition Swab test (KIS™ Test) or the Fast Antimicrobial Screen Test (FAST). These screens resulted in approximately 5,000 positive samples submitted to the FSIS Midwestern Laboratory for confirmation, and 1,045 of these samples were confirmed to be violative. Starting in August 2012, FSIS began to test in-plant screen positives using a multi-residue screening method. In addition, the new Tier 2 will includes directive-driven targeted testing at the production and compound class level as outlined in FSIS notices for sampling show animals, dairy cows, and bob veal calves. FSIS can adjust targeted sampling plans to respond to information about misuse of animal drugs and/or exposure to environmental chemicals gained from other agencies (such as FDA and EPA), as well as Tier 1 sampling data. FSIS is further planning a Tier 3 level, which FSIS 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 a herd or flock level. A targeted testing program designed for livestock or flocks originating 13 from the same farm or region may be necessary on occasion to determine the level of exposure of a chemical or chemicals to which the livestock or flock may have been exposed. Tier 3 will provide a vehicle for developing information that will support possible future policy development within the NRP. The import reinspection sampling program will be structured using the Tier 1 and 2 frameworks. In CY 2012, FSIS scheduled 1,300 import samples for collection. These import samples were comprised of 500 samples under the Tier 1 scheduled sampling and, based on interagency discussions, 800 samples under Tier 2. In addition, FSIS screened a subset of these samples for unknown compounds with the FSIS Food Emergency Response Network (FERN). FERN is a nation-wide integrated network of Federal, State, and local laboratories with the capability to detect and identify biological, chemical, and radiological agents in food. Note: FERN results are not reported in the Red Book. New Methodologies Based on interagency discussion and method improvements, FSIS began using a new screening method for antibiotics in the second half of 2012. The existing screening methodology for antibiotics was a 7-plate bioassay. The new multi-residue method (MRM) provides the following significant improvements: 1) it screens for a variety of analytes, not just antibiotics; 2) it has been validated at levels appropriate to tolerances; 3) it clearly distinguishes individual analytes, even if multiple drugs are present in the same sample, using mass spectrometry; 4) it mitigates unknown microbial inhibition responses; and 5) it reduces the time and personnel needed to obtain results. The FSIS pesticide method has been in place since 2011. This method diversifies testing capability, improving on the previous pesticide method. Specifically, while the previous method could only test for halogenated compounds; the new screen tests 57 pesticides across multiple classes and includes additional compounds. See Appendix II for a list of current methods used by FSIS laboratories. 14 Overview of the Sampling Plans The NRP 2012 Residue Sampling Plans focuses on chemical residues in domestic meat, poultry, and egg products and addresses import reinspection of meat and poultry. The domestic sampling plan includes scheduled sampling and inspector-generated sampling. The import reinspection sampling plan encompasses normal sampling, increased sampling, and intensified sampling. FSIS Directive, 10,800.1, rev 1, Procedures for Residue Sampling, Testing, and Other Responsibilities for the National Residue Program provides further detail. DOMESTIC SAMPLING PLAN Scheduled Sampling Scheduled sampling plans involve taking tissue samples from randomly selected food animals that have passed ante-mortem inspection. The development of scheduled sampling plans proceeded in the following manner for the first half of CY 20012: 1) determine which chemical compounds are of concern to food safety; 2) use algorithms to rank the selected chemical compounds; 3) pair these chemical compounds with appropriate food animals and egg products; and 4) establish the number of samples to be collected. The Surveillance Advisory Team (SAT), an interagency committee comprising of representatives from FSIS, FDA, EPA, AMS, ARS, and CDC, determines the chemical compounds and production classes (e.g., young chickens, bob veal, steers, etc.) of public health concern. FSIS calculates the number of samples needed for the scheduled sampling. The laboratories test the samples for the presence of chemical residues and report any positive findings above established tolerance levels, or when there is no established tolerance. The resulting violation data are used to verify whether industry process controls and HACCP plans effectively control residues. FSIS, FDA, and EPA review and make final adjustments to the domestic scheduled sampling plan. Inspector-Generated Sampling Inspector-generated sampling is conducted by in-plant Public Health Veterinarians (PHVs) when they suspect that animals may have violative levels of chemical residues. Currently, inspector-generated sampling targets individual suspect animals and suspect populations of animals and animals condemned for specific pathologies. When an inspector-generated sample is collected and the carcass is not already condemned, only the carcass that is sampled is held. If the in-plant screen test result is negative, the carcass is released. If positive, the carcass is held pending the results of laboratory 15 testing. The PHV makes a final determination on the carcass based on the confirmed laboratory results. Sampling for individual suspect animals The in-plant inspector selects a carcass for sampling based on professional judgment and public health criteria outlined in FSIS Directive 10,800.1, rev 1 (i.e., animal with disease signs and symptoms, producer history, or results from random scheduled sampling). Some samples are screened in the plant by IPP and verified when necessary by a PHV. Other samples are sent directly to the laboratory for analysis. For example, if the IPP suspects the misuse of a veterinary drug in an animal, she/he can perform the relevant in- plant screening test. If the result of a screening test is positive, the carcass is held (if not already condemned for other pathology or conditions that would make it unfit for human consumption), and the liver, kidney, and muscle sample from the carcass is sent to an FSIS laboratory for confirmation. Sampling for suspect animal populations Sampling for suspect animal populations is directed by an FSIS regulation (e.g., 9 CFR 310.21), directive (e.g., FSIS Directive 10,220.3) or FSIS notice. Actions taken on violations A violation occurs when an FSIS laboratory confirms a residue that exceeds an established tolerance or action level, or has no tolerance. Once the laboratory analysis is complete, FSIS enters the residue violation into the FSIS Residue Violation Information System (RVIS), an FSIS/FDA interagency database. FDA has on-farm jurisdiction and evaluates the appropriate action to take on the violation. These actions range in severity, from providing education to taking legal action. Every week, FSIS posts a Residue Repeat Violator List on its website. The list identifies producers with more than 1 violation on a rolling 12-month basis. In addition, the list provides helpful information to processors and producers who are working to avoid illegal levels of residues, serves as a deterrent for violators, and enables FSIS and FDA to make better use of resources. Because FSIS updates this list weekly, FDA may not have investigated each violation at the time of publication. 16 IMPORT REINSPECTION SAMPLING PLAN Imported meat, poultry, and egg products are sampled through the port-of-entry Import Reinspection Sampling Plan, a chemical residue-monitoring program conducted to verify the equivalence of inspection systems in exporting countries. All imported products are subject to reinspection, and one or more types of inspection (TOI) are conducted on product before it enters the United States. Chemical residue sampling is included in the reinspection of imported products. The following are the three levels of chemical residue reinspection: • • • Normal sampling: random sampling; Increased sampling: above-normal sampling resulting from an Agency management decision; and Intensified sampling: additional samples taken when a previous sample for a TOI failed to meet U.S. requirements. For both normal and increased sampling, the lot is not required to be retained pending laboratory results; however, the importer may choose to retain the lot pending the laboratory results. The lot is subject to recall if it is not retained and is found to contain violative levels of residue. For intensified sampling, the lot must be retained pending laboratory results. The data obtained from laboratory analyses are entered into the Public Health Information System (PHIS), an FSIS database designed to generate reinspection assignments, receive and store results, and compile histories for the performance of foreign plants certified by the inspection system in the exporting country. 17 Table 1. 2012 Estimated Slaughter Data by Production Class Production Class Beef cows Bulls Dairy cows Heifers Steers Bob veal Formula-fed veal Non-formula-fed veal Heavy calves Subtotal, Cattle Market hogs Roaster pigs Boars/Stags Sows Subtotal, Swine Lambs Sheep Goats Subtotal, Ovine Bison Total, All Livestock Young chickens Mature chickens Young turkeys Mature turkeys Ducks Geese Other fowl (include ratites) Subtotal, Poultry Rabbits Egg products Number of Head Slaughtered3 3,351,200 563,950 3,116,251 9,265,452 16,152,358 368,697 321,767 10,602 31,384 33,181,661 108,131,133 797,220 420,845 3,034,518 112,383,716 1,867,537 145,217 557,793 2,570,547 40,898 148,176,822 8,502,858,100 145,908,292 253,906,092 1,597,544 24,301,699 192,114 2,659,751 8,931,423,592 640,673 Not Applicable Pounds per Animal Total Pounds (dressed weight) 4 (dressed weight) 608 877 608 792 859 75 245 350 400 203 70 208 306 74 64 50 776 Not Reported Not Reported Not Reported Not Reported Not Reported Not Reported Not Reported Not Reported Not Applicable TOTAL, ALL PRODUCTION CLASSES 2,037,529,600 494,584,150 1,894,680,608 7,338,237,984 13,874,875,522 27,652,275 78,832,915 3,710,700 12,553,600 25,762,657,354 21,950,619,999 55,805,400 87,535,760 928,562,508 23,022,523,667 138,197,738 9,293,888 27,889,650 175,381,276 31,736,848 48,992,299,145 48,462,298,303 829,201,396 7,459,786,971 41,969,532 165,046,399 2,295,201 3,028,847 Percent Estimated Relative Production 1.842% 0.447% 1.713% 6.636% 12.547% 0.025% 0.071% 0.003% 0.011% 23.297% 19.849% 0.050% 0.079% 0.840% 20.819% 0.125% 0.008% 0.025% 0.159% 0.029% 44.303% 43.823% 0.750% 6.746% 0.038% 0.149% 0.002% 0.003% 56,963,626,649 1,830,105 4,627,887,131 51.511% 0.002% 4.185% 110,585,643,030 100% This table aims to estimate, for each individual production class for which FSIS has regulatory responsibility, the amount of domestically-produced product relative to the total for all of these production classes. FSIS estimated this value by assuming that the relative amount of each production class consumed would be approximately proportional to the total poundage (based on dressed weight) of each production class presented for slaughter or processing in federally inspected plants. Dressed weight, which represents the weight of the carcass after the hide, hoof, hair, and viscera have been removed, was used instead of live weight, because the former was thought to be more closely representative of total pounds consumed. Note: This table estimates the amount of domestically produced product that is consumed, regardless of who consumes it (i.e., no distinction is made between domestic products consumed domestically and products that are exported). 3 Number of heads is obtained from the Animal Disposition Reporting System (ADRS) and the Public Health Information System (PHIS). 4 Average dressed weights are obtained from the publication “Livestock Slaughter 2012 Summary” – April 2013- and “Poultry Slaughter 2012 Summary” –Feb 2013- by National Agricultural Statistics Service (NASS). In the absence of average weight, an average weight based on the previous calendar year’s data was used 18 Table 2. 2012 Summary of Import Volume by exported countries Country Net Weight Imported Percent Canada 1,372,905,219 43.73% Australia 622,544,811 19.83% New Zealand 408,276,453 13.00% Mexico 246,212,900 7.84% Uruguay 110,911,503 3.53% Denmark 83,988,493 2.68% Nicaragua 73,980,098 2.36% Chile 48,069,350 1.53% Brazil 40,427,361 1.29% Israel 40,202,908 1.28% Poland 20,969,454 0.67% Costa Rica 14,352,991 0.46% Honduras 14,262,673 0.45% Italy 12,380,401 0.39% Ireland 8,751,124 0.28% Netherlands 7,949,793 0.25% United Kingdom 3,286,147 0.10% Northern Ireland 2,057,636 0.07% Spain 1,957,556 0.06% Germany 1,644,974 0.05% These data are for meat and poultry imports. Finland 1,630,075 0.05% Egg product imports in 2012 = 13,118,996 pounds. Argentina 1,216,973 0.04% All egg product imports were from Canada. Hungary 483,245 0.02% Iceland 447,701 0.01% Croatia 327,873 0.01% France 77,662 0.00% Japan 61,007 0.00% Sweden 45,666 0.00% San Marino 3,716 0.00% Total Presented: 3,139,425,763 100.00% Note: FSIS regulations for meat list England, Scotland, and Wales under one inspection system, while Northern Ireland is listed separately under another inspection system. Furthermore; FSIS poultry regulations list Great Britain only. 19 Definitions of FSIS Animal Production Classes Bovine Beef cows are mature, female cattle bred for muscle development, ordinarily having given birth to one or more calves. • Bulls are mature, uncastrated male cattle. • Calves/veal: The agency is currently engaging in rulemaking to define “veal.” For sampling purposes under the NRP, veal calves are defined as immature cattle (including dairy breeds) lacking a functional rumen and intended for meat production. They are recognized as a separate class from suckling calves because of their handling, housing, and proximity to slaughter. • Dairy cows are mature, female cattle bred for milk production, ordinarily having given birth to one or more calves. • Heifers are young, female cattle more than 1 year old that have not yet given birth to a calf. • Steers are male cattle castrated before sexual maturity. Porcine • Boars are mature swine showing male sexual characteristics. Market hogs are swine, usually marketed near 6 months of age and 200 to 300 pounds live weight. • Roaster pigs are animals of both sexes and any age that are marketed with the carcass unsplit and with the head on. • Sows are mature, female swine, ordinarily having given birth to one or more litters. • Stags are male swine castrated after they have reached sexual maturity. Poultry • • • • • • • • • • Ducks are birds of both sexes and any age. Egg products include yolks, whites, or whole eggs after breaking; eggs are processed as dried, frozen, or liquid. Geese are birds of both sexes and any age. Mature chickens are adult female birds, usually more than 10 months of age. Mature turkeys are birds of both sexes and usually more than 15 months of age. Young chickens include broilers/fryers birds of both sexes that are usually less than 10 weeks of age. Roasters are birds of both sexes, usually less than 12 weeks of age; capons are surgically castrated male birds usually less than 8 months of age. Young turkeys include fryer/roaster birds that are of both sexes and usually less than 12 weeks of age. Other poultry include ratites (e.g., ostriches, emus, and rheas), guineas, squabs (young, unfledged pigeons), adult pigeons, pheasants, grouse, partridge, quail, etc. Other Livestock • • • Goats are animals of both sexes and any age. Lambs are sheep younger than 14 months and having a break joint in at least one leg. Rabbits are any of several lagomorph mammals of both sexes and any age. 20 Figure 1. National Residue Program: Domestic Scheduled Samples Flow Chart Note: The residue sample results with violation are also reported in the Residue Violation Information System (RVIS). 21 SUMMARY OF DOMESTIC DATA Table 3. Number of samples tested, by production class 2012 Domestic Sampling Plan (Scheduled and Inspector-Generated) Inspector-generated refers to KIS™ Test and FAST in-plant screening tests (not including COLLGEN, SHOW, or STATE) project names Production Class Beef Cows Boars/Stags Bob Veal Bulls Dairy Cows Formula-Fed Veal Goats Heavy Calves Heifers Lambs Market Hogs Mature Sheep Non-Formula-Fed Veal Roaster Pigs Sows Steers Young Chickens Young Turkeys Total Scheduled Samples Scheduled Baseline Samples Baseline Assessments Assessments Tier-1 Tier-1 US Fed Plants US State Plants 712 40 538 1 721 20 395 25 682 64 693 370 683 719 5,513 74* 29 39 33 325 Inspectorgenerated Samples, Suspect Animals FAST & KIS™ 19,417 154 42,755 2,331 99,385 1,021 541 865 3,717 1,129 18,074 473 1,786 1,546 10,089 11,371 214,654** Notes: * Two violative sow samples were detected in US state plants. ** A total of additional 210 inspector-generated samples were collected and sent to FSIS labs for analysis. These samples are associated with project names: COLLGEN, SHOW, and STATE. 22 Chemical Class Information Summary Antibiotics An antibiotic is a chemical substance that has the capability in dilute solutions to destroy or inhibit the growth of microorganisms. The widespread use of antibiotics over time has allowed microorganisms to adapt and develop resistance to these drugs. 7,8 Hence, inappropriate use and exposure to antibiotics can increase the risk of getting an infection that resists antibiotic treatment. 9 In addition, allergies to antibiotics have been reported in children and adults 10 and use of antibiotics in infants has been associated with childhood asthma. 11 FSIS tests different classes of antibiotics: aminoglycosides, beta-lactams, fluoroquinolones, macrolides, tetracyclines, and sulfonamides. 12 FDA has assigned tolerances to many of the antibiotics tested within the NRP. These tolerance levels are provided in the Code of Federal Regulations, Chapter 21. Arsenic 8 In humans, the predominant dietary source of arsenic is seafood, followed by rice/rice cereal, mushrooms and poultry13. Ingestion of inorganic arsenic can cause gastrointestinal irritation and decreased red and white blood cell production, which can result in fatigue, abnormal heart rhythm, and nervous system effects (e.g., pins and needles). High oral doses can cause death. Evidence suggests that following long-term exposure, children show lower IQ scores. Inorganic arsenic is a known human carcinogen1. FDA tolerance levels for Arsenic are provided in the Code of Federal Regulations, Chapter 21. Avermectins (Ivermectin and Doramectin) and Milbemycins (Moxidectin) Avermectins (ivermectin and doramectin) and milbemycins (moxidectin) are macrocyclic lactones used in animal husbandry practices to prevent nematode and arthropod parasites. Ivermectin is an effective parasiticide. Doramectin is a potent endectocide that combines broad-spectrum activity with a prolonged duration of activity against the major internal and external parasites of cattle. Moxidectin is an antiparasitic drug that controls a range of internal and external parasites in 7 http://www.cdc.gov/drugresistance/about.html http://www.cdc.gov/drugresistance/pdf/public-health-action-plan-combat-antimicrobial-resistance.pdf 9 http://www.cdc.gov/getsmart/antibiotic-use/know-and-do.html 10 JM Langley and S Halperin (2002) Can J Infect Dis, 13(3):160-163 and http://www.allergy.org.au/healthprofessionals/hp-information/asthma-and-allergy/allergic-reactions-to-antibiotics 11 Risnes et al. (2011) Am J Epidemiol, 173:310–318 12 http://www.fsis.usda.gov/Science/Chemistry_Lab_Guidebook/index.asp 8 The method reduces organic arsenic to inorganic arsenic prior to quantification. The reported results include both original organic and inorganic arsenic species. 8 13 http://www.atsdr.cdc.gov/ToxProfiles/tp2.pdf 23 sheep and cattle. Avermectins share their common antiparasitic activity via interaction at cell membrane receptors; mammals are less susceptible to the toxic effects because avermectins do not readily cross the blood-brain barrier. Nevertheless, adults and children are susceptible to effects on the nervous system. These effects include nausea and vomiting, dizziness, coma, and potentially death at high doses. 14 FDA has assigned tolerances to many of the Avermectins across production classes. These tolerance levels are provided in the Code of Federal Regulations, Chapter 21. beta-Agonists (Clenbuterol, Cimaterol, Ractopamine, Salbutamol, and Zilpaterol) Beta-agonists are used for growth promotion in food animals, increasing lean muscle mass. Clenbuterol, a growth promotant, is not currently registered for use in livestock in the U.S. and is listed in AMDUCA as prohibited from extra-label use in animals intended for food. Ractopamine is used for increased rate of weight gain, improved feed efficiency, increased carcass leanness, and prevention and/or control of porcine proliferative enteropathies (ileitis). Zilpaterol is used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. While the other beta-agonists are approved for use in the United States, cimaterol and salbutamol are not approved for use in food animals. In humans, clenbuterol and salbutamol are used as bronchodilators by asthma sufferers and as performance-enhancing drugs by athletes. Human side effects include increased heart rate and blood pressure, anxiety, palpitation and skeletal muscle tremors. The prolonged use of long-acting beta agonists can lead to the severe exacerbation of asthma symptoms 15. All FDA-approved uses and tolerances for betaAgonists are provided in the Code of Federal Regulations, Chapter 21. Carbadox Carbadox is a growth-promoting and antibacterial drug 16 approved to prevent or treat intestinal track inflammation (enteritis), as well as to improve feed efficiency and weight gain in swine. Carbadox and some of its metabolites (desoxycarbadox and hydrazine) are genotoxic and carcinogenic in rodents; however, the final metabolite, quinoxaline-2-carboxylic acid is not mutagenic or carcinogenic in animals. All FDA-approved uses and tolerances for Carbadox are provided in the Code of Federal Regulations, Chapter 21. 14 http://www.asiatox.org/6th%20APAMT%20pdf/Mectins%20posioning%20vs%20Avermectin%20poison ing.pdf 15 http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm219161.htm http://www.inchem.org/documents/jecfa/jecmono/v27je07.htm and http://www.inchem.org/documents/jecfa/jecmono/v51je05.htm 16 24 Chloramphenicol Chloramphenicol is a potent, broad-spectrum antibiotic with severe toxic effects in humans: bone marrow suppression or aplastic anemia in susceptible individuals. While microorganisms have developed resistance to the drug, it is still used selectively to treat bacterial infections. This drug is AMDUCA-prohibited for extra label use in animals intended for food. Chloramphenicol is not approved for use in food-producing animals. Chlorinated Hydrocarbons and Chlorinated Organophosphates (Pesticides) Chlorinated hydrocarbons, chlorinated organophosphates, organophosphates, and pyrethroids are effective insecticides 17. Some of these compounds, such as DDT, are no longer marketed because of their extremely slow degradation in the environment (long half-life). Organophosphates and pyrethroids affect the nervous system, generally by disrupting the enzyme that regulates the neurotransmitter-acetylcholine. Typical symptoms of acute intoxication are headaches, dizziness, muscle twitching, weakness, tingling sensations, and nausea 18. Children are at greater risk to some pesticides because their developing organs offer less protection than those of adults 19. Chlorinated hydrocarbons, especially polychlorinated hydrocarbons (PCBs), can cause cancer. 20 Noncancer effects in animals include effects on the immune system, the reproductive system, the nervous system, and the endocrine system.4 EPA has assigned tolerances to many of the pesticides tested within the NRP. These tolerance levels are provided in the Code of Federal Regulations, Chapter 40. Florfenicol Florfenicol is a broad-spectrum bacteriostatic antibiotic. It is typically used to treat cattle (bovine respiratory disease and foot rot) 21, although it has recently been approved for freshwater fish 22. Horses and other equine animals may experience diarrhea. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy 23. All FDA-approved uses and tolerances for Florfenicol are provided in the Code of Federal Regulations, Chapter 21. 17 http://www.epa.gov/pesticides/about/types.htm#chemical http://www.epa.gov/oppfead1/Publications/whatyouneed-hsstaff.pdf 19 http://www.epa.gov/pesticides/food/pest.htm 20 http://www.epa.gov/epawaste/hazard/tsd/pcbs/pubs/effects.htm 18 21 http://www.nuflor.com/ http://www.merck-animal-health-usa.com/products/130_163256/productdetails_130_163418.aspx 23 http://intervetus.naccvp.com/?m=product_view&u=intervetus&p=intervetus&id=1047137 22 25 Flunixin Flunixin is a non-steroidal anti-inflammatory drug (NSAID) with approved use in swine and cattle to alleviate inflammation and pain associated with musculoskeletal disorders. In general, NSAIDs in animals and humans can produce gastrointestinal (GI) side effects if the drug is taken at high doses over a prolonged period of time. GI ulceration is the most common side effect; however, kidney damage and bleeding problems can also occur 24. All FDA-approved uses and tolerances for Flunixin are provided in the Code of Federal Regulations, Chapter 21. Nitrofurans Nitrofurans are synthetic chemotherapeutic agents with a broad antimicrobial spectrum 25. Furaltadone is a synthetic nitrofuran antibiotic used to prevent intestinal infections and mastitis. It is not approved for use in food-producing animals. Furazolidone, which has wide-ranging applicability, is used to treat intestinal infections and is AMDUCA-prohibited for extra-label use. In small calves, overuse can lead to neurotoxicity (head tremors, ataxia, visual impairment, and convulsions). Nitrofurans are potentially carcinogenic and are not generally recognized as safe under any conditions of intended use that may reasonably be expected to result in their becoming a component of food 26. Nitrofurans are not approved for use in food-producing animals. Nitroimidazoles Nitroimidazoles, such as dimetridazole and ipronidazole, are used to treat bacterial infections and parasites, but are AMDUCA-prohibited for extra-label use. For human health, the main targets for toxicity are the gastrointestinal tract and the nervous system 27. Allergic reactions (skin rash, itching) may also occur 28. Nitroimidazoles are not approved for use in food-producing animals. 24 http://www.merckvetmanual.com/mvm/index.jsp?cfile=htm/bc/191606.htm&word=flunixin http://www.merckvetmanual.com/mvm/index.jsp?cfile=htm/bc/191283.htm 26 http://www.accessdata.fda.gov/cms_ia/importalert_33.html 27 Roe FJC (1984) Safety of Nitroimidazoles; http://www.pnlee.co.uk/documents/FJCR_CV/ROE1984L.pdf and http://www.merckvetmanual.com/mvm/index.jsp?cfile=htm/bc/191284.htm 28 http://www.antibioticslist.com/nitroimidazoles.html 25 26 Sulfonamides Sulfonamides are a group of drugs used to treat infections. Some of these drugs have bacteriostatic action. Oral exposure to sulfonamides can lead to hypersensitivity reactions (e.g. rashes and Stevens-Johnson Syndrome), effects on urine, effects on blood, photosensitivity and effects on the nervous system (e.g., insomnia and headaches). As with other antibiotics, microorganisms are developing resistance to this class of drugs. All FDA-approved uses and tolerances for Sulfonamides are provided in the Code of Federal Regulations, Chapter 21. 27 2012 NRP Domestic Residue Scheduled Sampling The U.S. National Residue Program (U.S. NRP) samples on a calendar-year basis for meat, poultry and processed egg products, and constitutes a risk-based, FSIS headquarters-driven testing program. The NRP Residue sampling plans focus on chemical residues in domestic meat and poultry products. The domestic sampling plan includes scheduled sampling plans involve random tissue sampling from food animals that have passed ante-mortem inspection. Under the scheduled sampling program in calendar year (CY) 2012, FSIS tested nine Slaughter Classes (beef cows, bob veal, dairy cows, heifers , steers, , market hogs, sows, young chickens, and young turkeys) representing 95% of domestic meat and poultry slaughter production. In July 2012, FSIS announced in a Federal Register Notice (FRN) that the Agency was restructuring the U.S. NRP with respect to how sampling of chemical compounds and animal production and egg product classes is scheduled. Concurrently, FSIS implemented several multi-residue methods for analyzing samples of meat, poultry, and processed egg products for animal drug residues, pesticides, and environmental contaminants in its inspector-generated testing program. These modern, high-efficiency methods will conserve Agency resources and provide useful and reliable results while enabling FSIS to analyze each sample for more compounds. In August 2012, FSIS implemented a new sampling program using two new multiresidue chemical methods for the scheduled program. Because the screens are capable of evaluating multiple classes of veterinary drugs in each sample. FSIS discontinued the practice of testing slaughter classes for a single compound or chemical classes “paired sampling,” i.e. testing one sample for a single chemical or chemical compound class. 28 DOMESTIC RESIDUE SCHEDULED SAMPLING RESULTS Pre-August This section reports the summary results from the FSIS Domestic Scheduled Sampling Plan. The preliminary summary results are presented by compound class and slaughter class. Data Source: FSIS PHIS database. Table 4 contains the summary of domestic scheduled sampling results and provides the number of samples analyzed by compound class. column 1: lists the compound class, column 2: the number of samples, column 3: the number of non-violative positives (e.g., compounds detected at a level equal to or below the established tolerance), and column 4: the number of violations. Tables 5-14 contain the summary of domestic scheduled sampling results, and provide the number of samples analyzed by slaughter class. column 1: lists the compound class, column 2: the number of samples, column 3: the number of non-violative positives (e.g., compounds detected at a level equal to or below the established tolerance), and column 4: the number of violations. Table 15 summarizes violation results by Slaughter Class. These include chemical compound class (column 2), chemical residue (column 3), tissue type (column 4), and residue detected results in ppb or ppm (column 5). Note: Residue detected results with “8888” indicate instances when residues were detected, but were not quantitated. Post-August Table 15 lists the chemical classes – including the new methods- associated with slaughter classes. Tables 16 contain the summary of domestic scheduled sampling number of samples (animal) analyzed, and analyses done by slaughter class: column 2: number of non-detected samples, column 3: number of non-violative positive samples, column 4: number of confirmed violative samples, column5: number of detected (non-regulated) samples, column 6: number of nondetected (non-regulated) samples, and column 7: total number of samples. Tables 17 contain the summary of domestic scheduled sampling number of analyses done by slaughter class: column 2: number of non-detected analyses, column 3: number of non-violative positive analyses, column 4: number of confirmed violative analyses, colum5: number of detected (non-regulated) analyses, column 6: number of non-detected (non-regulated) analyses, and column 7: total number of analyses done. Table 18 summarizes violation results by slaughter Class. These include chemical compound class (column 2), chemical residue (column 3), tissue type (column 4), and residue detected results in ppb or ppm (columns 5). Note: Residue detected results with “8888” indicate instances when residues were detected, but were not quantitated. 29 Slaughter Class Pre-August Results Table 4: Total Number of Samples by Slaughter Class 2012 Domestic Scheduled Sampling Plan (Pre-August) Number of NonDetect Samples Number of Nonviolative Positives Number of NonRegulatory Samples * Total Samples 0 Number of LabConfirmed Violative Samples 0 Beef Cows 423 2 Bob Veal 307 1 0 6 314 Dairy Cows 429 3 0 0 432 Heifers 234 2 0 0 236 Steers 215 2 0 0 217 Market Hogs* 336 1 70 0 407 Sows 413 1 0 0 414 Young Chickens 405 0 0 0 405 Young Turkeys 432 0 0 0 432 3,194 12 70 6 3,282 Slaughter Class TOTAL 425 Note: *(Exploratory assessment) sample for Lead and Cadmium Table 5. Beef Cows Summary (Pre-August) 2012 Domestic Scheduled Sampling Plan Number of Non-Detect Samples Number of Non-violative Positives Number of LabConfirmed Violative Samples Avermectins 132 2 0 134 Antibiotics-FlunixinSulfonamides 291 0 0 291 TOTAL 423 2 0 425 Compound Class 30 Total Samples Table 6. Bob Veal Summary (Pre-August) 2012 Domestic Scheduled Sampling Plan Compound Class Number of NonDetect Samples Number of Non-violative Positives Number of LabConfirmed Violative Samples Antibiotics-FlunixinSulfonamides 307 1 6 314 TOTAL 307 1 6 314 Total Samples Table 7. Dairy Cows Summary (Pre-August) 2012 Domestic Scheduled Sampling Plan Compound Class Number of Non-Detect Samples Number of Nonviolative Positives Number of LabConfirmed Violative Samples Antibiotics-FlunixinSulfonamides 187 1 0 188 Avermectins 89 2 0 91 Pesticides/Herbicides 77 0 0 77 Furazolidone-Furaltodone 76 0 0 76 TOTAL 429 3 0 432 Total Samples Table 8. Heifers Summary (Pre-August) 2012 Domestic Scheduled Sampling Plan Compound Class Number of Non-Detect Samples Number of Non-violative Positives Number of LabConfirmed Violative Samples Total Samples Antibiotics-Sulfonamides 120 0 0 120 beta-Agonists 114 2 0 116 TOTAL 234 2 0 236 31 Table 9. Steers Summary (Pre-August) 2012 Domestic Scheduled Sampling Plan Number of Non-Detect Samples Number of Nonviolative Positives Number of LabConfirmed Violative Samples Antibiotics-Sulfonamides 33 0 0 33 Avermectins 49 0 0 49 Florfenicol 47 0 0 47 Pesticides/Herbicides & beta Agonists 86 2 0 88 TOTAL 215 2 0 217 Compound Class Total Samples Table 10. Market Hogs Summary (Pre-August) 2012 Domestic Scheduled Sampling Plan Number of Non-Detect Samples Number of Nonviolative Positives Number of NonRegulatory Samples * Number of LabConfirmed Violative Samples Total Samples Arsenic 67 0 0 0 67 Antibiotics-Sulfonamides 66 0 0 0 66 beta Agonists & Carbadox 136 1 0 0 137 Lead and Cadmium * 0 0 70 0 70 Furazolidone & Furaltodone 67 0 0 0 67 TOTAL 336 1 70 0 407 Compound Class Note: *(Exploratory assessment) sample for Lead and Cadmium Table 11. Sows Summary (Pre-August) Number of Non-Detect Samples Number of Non-violative Positives Number of LabConfirmed Violative Samples Total Samples Antibiotics-Sulfonamides 236 1 0 237 Pesticides/Herbicides 177 0 0 177 TOTAL 413 1 0 414 Compound Class 32 2012 Domestic Scheduled Sampling Plan Table 12. Young Chicken Summary (Pre-August) 2012 Domestic Scheduled Sampling Plan Compound Class Number of Non-Detect Samples Number of Nonviolative Positives Number of LabConfirmed Violative Samples Chloramphenicol & Arsenic 133 0 0 133 Antibiotics-Sulfonamides 138 0 0 138 Pesticides/Herbicides 134 0 0 134 TOTAL 405 0 0 405 Total Samples Table 13. Young Turkeys Summary (Pre-August) 2012 Domestic Scheduled Sampling Plan Number of Non-Detect Samples Number of Non-violative Positives Number of LabConfirmed Violative Samples Total Samples 143 0 0 143 Chloramphenicol & Arsenic 288 0 0 289 TOTAL 432 0 0 432 Compound Class Antibiotics-Sulfonamides Table 14. Violations Report (Pre-August) 2012 Domestic Scheduled Sampling Plan Slaughter Class Compound Class Residue Tissue Result (ppm) Bob Veal Antibiotics Dihydrostreptomycin Kidney 4.37 Bob Veal Antibiotics Neomycin Kidney 8.14 Antibiotics Penicillin Kidney 0.23 Antibiotics Gentamycin Sulfate Bob Veal Antibiotics Dihydrostreptomycin Kidney 4.11 Bob Veal Antibiotics Tilmicosin Liver 3.78 Bob Veal Antibiotics Neomycin Kidney 7.21 Bob Veal 33 8888* Post –August Results Beginning August 2012, FSIS implemented a new sampling program using new multiresidue chemical methods for the scheduled program. Because the screens are capable of evaluating multiple classes of veterinary drugs, each individual sample was tested for hundreds of chemical Table 15. List of chemical class –including the new methods, associated with slaughter classes (Post-August 2012) Slaughter Class by Compound Class *CY 2012*: Aug-Dec Beef Cows Bob veal Dairy cows Heifers Multi-class (52) √ √ √ Aminoglycoside (9) √ √ Pesticides (56) √ Methods/Classes (# of Chemical Residues) Metals (7) beta-agonists (5) Avermectins (3) Steers Market hogs Sows √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Carbadox Young turkeys √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Nitrofurans (2) Arsenic Young chickens √ √ √ √ √ 34 √ √ √ √ √ Table 16. Total Number of Samples by Slaughter Class 2012 Domestic Scheduled Sampling Plan (Post-August) Number of NonDetect Samples Number of Nonviolative Positives Number of LabConfirmed Violative Samples Total Samples Beef Cows 287 Number of NonDetect NonRegulated Samples 0 0 0 287 Bob Veal 218 3 3 0 224 4 0 0 289 Slaughter Class Dairy Cows 285 Heifers 157 2 0 0 159 Steers 150 2 1 0 153 Market Hogs 271 2 2 0 275 Sows 278 1 0 0 279 Young Chickens 278 0 0 0 278 Young Turkeys TOTAL 287 0 14 0 6 0 0 287 2,231 2,211 Table 17: 2012 Domestic Scheduled Sampling Plan (Post-August) Number of analyses per production class. Note: There were many analyses performed on each sample. Slaughter Class Beef Cows Bob Veal Dairy Cows Number of NonDetect Analyses Number of Nonviolative Positives Analyses Number of LabConfirmed Violative Analyses Number of Detect (Non Regulated Analyses) Number of Non-Detect (Non Regulated Analyses) Total Number of Analyses Performed 25,878 0 0 5 298 26,181 3 4 6 0 2 1 332 343 20,050 25,253 2 0 20 210 13,803 19,707 24,905 Heifers 13,571 Steers Market Hogs Sows Young Chickens 13,197 24,423 24,281 7,482 3 2 1 0 1 3 0 0 14 5 4 2 221 305 364 2947 13,436 24,738 24,650 7,781 Young Turkeys TOTAL 7,045 0 15 0 10 3 56 345 2,715 7,393 163,285 160,489 35 Table18. Violations Report (Post-August) 2012 Domestic Scheduled Sampling Plan Slaughter Class Compound Class Residue Bob Veal Sulfonamides Sulfamethazine Tissue Result (ppm) Muscle 14.21 Liver 13.73 Muscle 1.60 Liver 0.93 Liver 110.81 Muscle 100.79 Bob Veal Sulfonamides Bob Veal Sulfonamides Steer Sulfonamides Sulfamethazine Liver 0.30 Market hogs Antibiotics Lincomycin Kidney 8888* Liver 0.482 Muscle 0.12 Market hogs Sulfadimethoxine Sulfamethazine Sulfonamides Sulfamethazine 36 2012 Domestic Residue Scheduled Sampling -Targeted Assessments Environmental Contaminants (Cadmium and Lead) In 2012, FSIS conducted a survey of the prevalence of cadmium and lead in nine animal classes, collecting 558 samples (in parenthesis), which yielded 1,197 analysis results from muscle and kidney tissues. Muscle and kidney samples with cadmium levels below the Minimum Level of Applicability9 (i.e., 10 ppb for cadmium and 25 ppb for lead) are labeled as non-detect (ND) in Tables 19 and 20. Table 19 presents the number of positives and ND analyses by metal and tissue analyzed. Table 19. Number of Positive and Non-detect samples analyses tested for Cadmium and Lead, 2012 Targeted Assessments Results Number of Analyses Animal Class / (Number of Samples ) Non Detect Positive 10 Total Animal Compound Tissue Beef Cow (54) Cadmium Muscle 54 0 54 Lead Muscle 53 1 54 Cadmium Muscle 57 0 57 Lead Muscle 57 0 57 Cadmium Muscle 62 0 62 Lead Muscle 62 0 62 Cadmium Muscle 40 0 40 Lead Muscle 40 0 40 Kidney 0 70 70 Muscle 130 0 130 Kidney 49 4 53 Muscle 88 0 88 Bob Veal (57) Dairy Cow (62) Heifer (40) Market Hogs (130) Cadmium Lead 9 Minimum Level of Applicability: The minimum level at which a method has been validated. Positive samples have detectable Minimum levels above 10 ppb for cadmium and 25 ppb for lead. 10 37 Continued: Table 19. Number of Positive and Non-detect samples analyses tested for Cadmium and Lead, 2012 Targeted Assessments Results Number of Analyses Animal Class / (Number of Samples ) Non Positive 10 Animal Compound Tissue Detect Sow (64) Cadmium Muscle 64 0 64 Lead Muscle 63 1 64 Cadmium Muscle 40 0 40 Lead Muscle 40 0 40 Cadmium Muscle 52 0 52 Lead Muscle 52 0 52 Cadmium Muscle 59 0 59 Lead Muscle 59 0 59 1,121 76 1,197 Steer (40) Young Chicken (52) Young Turkey (59) TOTAL (558) 10 Positive samples have detectable levels above 10 ppb for cadmium and 25 ppb for lead. 38 Total . Table 20. Cadmium and Lead Levels in Kidneys and Muscles, by Animal Class, 2012 Targeted Assessments Results Animal Class Metal Tissue Number of Positive Analyses Range (ppb) Median Levels (ppb) Mean Levels (ppb) Standard Deviation 95th percentile Beef Cows Lead Muscle 1 33.94 33.94 N/A N/A N/A Market Hogs Cadmium Kidney 70 20.74- 424.74 99.81 137.90 94.79 368.60 Market Hogs Lead Kidney 4 32.85- 102.20 66.24 66.87 28.38 102.20 Sows Lead Muscle 1 30.48- 30.48 N/A N/A N/A N/A All values presented in the table are applicable to positive analyses only. 39 2012 Domestic Residue Scheduled Sampling: Inspector-Generated Sampling Public Health Veterinarian (PHVs), and Consumer Safety Inspectors (CSIs) under the guidance of a PHV, conduct inspector-generated sampling when an animal is suspected to have undergone drug treatment and possibly contains violative levels of chemical residues. Sample screening utilizes the FAST or the KIS™ Test. If FAST supplies or KIS™ Test kits are not available, the PHV submits the sample to the FSIS laboratory for testing. FSIS has been incorporating the KIS™ Test in all slaughter plants since August 2011, and FSIS intends to phase in the KIS™ Test as the only in-plant screening test for the Agency in CY2012. Table 21 summarizes the total number of in-plant screen tests using the FAST or the KIS™ Test. This includes the number of in-plants screens tests with negative results, and the number of positive in-plant screens tests that were sent to FSIS labs for confirmation. Table 22 summarizes the total number of samples analyzed and the number of animals with violations for each production class. Column 1 lists the production classes and columns 2-6 show the number of samples and violations for COLLGEN, FAST, KIS, SHOW and STATE projects respectively. Tables 23 identifies the results for specific compounds that were detected (violative) within the production class across inspector-generated projects names (i.e., COLLGEN, FAST, KIS™, etc.) respectively. Column 1 lists the production class and the remaining columns list the specific project names. Tables 24-25 identifies the results for specific chemical compounds that were detected (violative) within several inspector generated project names, and within production class across inspector-generated program respectively. Similarly, the inspector-generated sampling results for non-violative positive residue samples are detailed in Tables 26-28. Table 26 identifies the results for specific compounds that were detected (non-violative) within the production class across inspector-generated projects names (i.e. COLLGEN, FAST, KIS™, etc.) respectively. Column 1 lists the production class and the remaining columns list the specific project names. Tables 27-28 identifies the results for specific chemical compounds that were detected (non-violative) within several inspector-generated projects, within production class across inspector-generated program respectively. 40 1. Samples Screened In-plant and Confirmed in an FSIS Laboratory Fast Antimicrobial Screen Test (FAST) FSIS IPP used FAST kits to screen 14,655 samples for antibiotic and sulfonamide residues. Inplant positive samples were sent to the labs to repeat the FAST. These FAST-positive samples were also analyzed for flunixin, a non-steroidal, anti-inflammatory compound. FSIS laboratories confirmed 41 violations in 29 animals. The most violative residue was Penicillin (26); also detected were Flunixin (5), and Sulfamethazine (4). Kidney Inhibition Swab (KIS™) Test FSIS IPP used KIS™ Test kits to screen 199,999 samples for antibiotic and sulfonamide residues. In-plant positive samples were sent to the labs to repeat the KIS™ Test. These KIS™positive samples were analyzed for flunixin, a non-steroidal, anti-inflammatory compound. FSIS laboratories confirmed 1,125 violations in 900 animals. The three most violative chemicals residue results were: Penicillin (244), Neomycin (209), and Desfuroylceftiofur Cystine Disulfide (DCA) (172). 2. Samples Confirmed in an FSIS Laboratory Collector-Generated (COLLGEN) FSIS IPP analyzed samples collected from 79 animals for antibiotic and sulfonamide residues. FSIS laboratories confirmed 2 violations: Oxytetracycline, and Penicillin, in beef cow and market swine, respectively. Show Animals (SHOW) Analyses were conducted for antibiotic and sulfonamide residue in 85 animals, including 4 heifers, 8 lambs, 62 market hogs, and 20 steers. One violation, Sulfamethazine in a market hog, was detected. State or Government Agency Testing (STATE) Analyses were conducted for antibiotic and sulfonamide residue in 46 animals. Twelve violatives residue results were in five animals (market swine, heifer, and steer) were found. The violative residues were: Sulfamethazine (8), Penicillin (3), and Zeranol (1). 41 Table 21: Summary Results, 2012 Inspector-Generated Sampling (by Test Type) Number of In-plant screens tests performed at Plants/Plants Production Class Beef Cows Boars/Stags Bob Veal Bulls Dairy Cows Formula-Fed Veal Goats Heavy Calves Heifers Lambs Market Hogs Mature Sheep Non-Formula-Fed Veal Roaster Pigs Sows Steers Total * 4 37 10 7 13 309 29 14 662 7,251 304 FAST Number of In-plant (screened) Positive Samples 1 2 2 8 0 5 86 3 2 808 4,974 10 14,434 Number of In-plant (screened) Negative Samples • Total FAST In-plant (screened) Samples Number of In-plant (screened) Negative Samples 5 37 10 7 15 311 37 14 667 7337 307 18,868 114 41,943 2,245 96,555 989 227 768 3,586 460 10,663 166 - 2 1,677 34 80 221 842 5054 10 14,655 700 4,926 11,145 195,032 KIS™ * Number of In-plant (screened) Positive Samples 554 3 802 79 2,815 32 3 60 117 2 74 - Total KIS™ Inplant (screened) Samples TOTAL Number of In-plant (screened) Negative Samples Number of In-plant (screened) Positive Samples 19,412 117 42,745 2,324 99,370 1,021 230 828 3,703 462 10,737 166 18,872 151 41,953 2,252 96,568 989 536 797 3,600 1122 17,914 470 545 3 802 79 2817 32 5 68 117 7 160 3 19,417 154 42,755 2,331 99,385 1,021 541 865 3,717 1,129 18,074 473 107 1,784 1,679 107 1,786 4 109 216 4,967 704 5,035 11,361 199,999 1,508 9,900 11,155 209,466 38 189 216 5,188 1,546 10,089 11,371 214,654 Samples that are FAST and/or KIS™ Test positive in the plant are further analyzed for flunixin and phenylbutazone in the laboratory 42 Total In-plant (screened) Samples Table 22: 2012 Inspector-Generated Sampling Results: Summary of Violative Residue Animals by Project Name COLLGEN Production Class Number of Samples Number of Animals With Confirmed Lab Violations 1 - FAST * Number of In-plant (screened) Positive Samples Number of Animals With Confirmed Lab Violations 1 KIS ™ * Number of In-plant (screened) Positive Samples Number of Animals With Confirmed lab Violations 63 283 8 419 SHOW Number of Samples Number of Animals With Confirmed Lab Violations - 3 1 554 Beef Cows 1 Boars/Stags 3 Bob Veal 8 802 Bulls 1 79 Dairy Cows 22 2 2,815 Formula-Fed 32 1 Veal Goats 2 2 3 3 Heavy Calves 8 4 60 5 Heifers 2 117 2 16 Lambs 1 5 2 2 7 Market Hogs 12 86 4 74 51 1 6 1 Mature Sheep 3 2 Non-Formula1 107 23 Fed Veal Roaster Pigs 1 34 4 Sows 2 80 17 109 45 Steers 18 216 19 31 ** Other 6 79 221 4,967 85 Total 2 28 900 1 * Cattle samples that are FAST and/or KIS™ Test positive in the plant are further analyzed for flunixin in the laboratory ** Other represents samples submitted without identification of production class. 43 STATE Number of Samples 3 1 5 Number of Animals With Confirmed Lab Violations - 2 2 3 1 11 1 6 - 2 8 8 46 1 1 8 Table 23: 2012 Inspector-Generated Sampling Results: Distribution of Violative Residues by Production Class and Project Name Note: Multiple violative residue results may be associated a single sample (animal) Project Name Production Class FAST Beef Cows -- Bob Veal -- Bulls -- KIS™ Test COLLGEN 81 1 371 13 Dairy Cows 2 501 Formula-Fed Veal -- 1 Heavy Calves 8 6 Heifers -- 20 Lamb 3 Market Swine 4 11 Non-Formula-Fed Veal -- 27 Sows 24 54 Steers -- 40 41 1,125 SHOW STATE Total -- -- 82 -- -- -- 371 -- -- -- 13 -- -- -- 503 -- -- -- 1 -- -- -- 14 -- -- 1 21 -- -- -- 3 1 2 10 28 -- 27 -- 78 -- 1 41 2 12 1,182 ---2 TOTAL 44 -- Table 24: 2012 Inspector-Generated Sampling Results: Distribution of Violative Residue by Chemical Residue and Project Name Note: Multiple violative residue results may be associated with a single sample (animal) Project Name Chemical Residue Amikacin Ampicillin Cefazolin Ciprofloxacin Desethylene Ciprofloxacin Desfuroylceftiofur Cystine Disulfide Dexamethasone Dihydrostreptomycin Enrofloxacin Florfenicol Flunixin Gamithromycin Gentamycin Sulfate Lincomycin Naficillin Total FAST KIS ™ Test COLLGEN SHOW STATE -----1 ----5 ---1 1 15 1 4 1 172 2 15 2 17 96 3 40 1 -- ---------------- ---------------- ---------------- 45 1 15 1 4 1 173 2 15 2 17 101 3 40 1 1 Continued: Table 24. 2012 Inspector-Generated Sampling Results: Distribution of Violative Residue by Chemical Residue and Project Name Note: Multiple violative residue results may be associated with a single sample (animal) Project Name Chemical Residue Total FAST KIS ™ Test COLLGEN SHOW STATE Neomycin -- 209 -- -- -- 209 Oxytetracycline 2 33 1 -- -- 36 Penicillin 26 244 1 -- 3 274 Sulfadiazine -- 1 -- -- -- 1 Sulfadimethoxine 2 86 -- -- -- 88 Sulfadoxine -- 2 -- -- -- 2 Sulfaethoxypyridazine -- 2 -- -- -- 2 Sulfamethazine 4 82 -- 2 8 96 Sulfamethoxazole -- 41 -- -- -- 41 Tetracycline Tilmicosin -- 5 -- -- -- 5 -- 46 -- -- -- 46 Tulathromycin -- 3 -- -- -- 3 Tylosin -- 1 -- -- -- 1 Zearalanol -- -- 1 1 Total 41 1,125 12 1,182 2 46 2 -- -- -- -- -- -- -- -- 1 Ampicillin -- 1 -- 13 1 -- -- -- -- -- -- -- 15 Cefazolin -- -- 1 -- -- -- -- -- -- -- -- 1 Ciprofloxacin -- 2 -- -- -- -- 1 -- 1 -- -- -- 4 Desethylene Ciprofloxacin -- 1 -- -- -- -- -- -- -- -- -- -- 1 Desfuroylceftiofur Cystine Disulfide 4 26 -- 130 -- 1 4 -- -- -- 1 7 173 Dexamethasone Dihydrostreptomycin --- 2 5 --- -10 --- --- --- --- --- --- --- --- 2 10 Enrofloxacin -- 2 -- -- -- -- -- -- -- -- -- -- 2 Florfenicol 9 1 2 -- -- 1 -- -- -- -- 4 17 Flunixin 11 19 -- 59 -- 8 1 -- -- -- -- 3 101 Gamithromycin -- 3 -- -- -- -- -- -- -- -- -- -- 3 Gentamycin Sulfate 2 5 1 19 -- -- 2 -- -- 3 -- 8 40 Lincomycin -- -- -- -- -- -- -- -- 1 -- -- -- 1 Naficillin -- -- -- -- -- -- -- -- -- -- 1 -- 1 47 Bob Veal Total Market 1 Steers Lamb -- Sows Heavy Calf -- Swine Formula-fed Veal -- Heifer Dairy Cow Amikacin Chemical Residue Beef Cows Bulls Non Formula Fed Veal Table 25: 2012 Inspector-Generated Sampling Results: Distribution of Residue Violations, By Chemical Residue, and Animal Class (Includes FAST and KIS™ Tests) Note: Multiple violative residue results may be associated with a single sample (animal) Beef Cows Bob Veal Bulls Dairy Cow Formula-fed Veal Heavy Calf Heifer Lamb Market Swine Non Formula -Fed Veal Sows Steers Total Continued: Table 25. 2012 Inspector-Generated Sampling Results: Distribution of Residue Violations, By Chemical Residue, and Animal Class (Includes FAST and KIS™ Tests) Note: Multiple violative residue results may be associated a single sample (animal) Neomycin -- 188 -- 6 -- -- 1 -- -- 14 -- -- 209 Oxytetracycline 12 12 4 5 -- -- 1 2 -- -- -- -- 36 Penicillin 21 13 2 147 -- 1 4 -- 5 -- 75 6 274 Sulfadiazine -- 1 -- -- -- -- -- -- -- -- -- -- 1 Sulfadimethoxine -- 15 -- 62 -- 1 1 1 -- 4 4 88 Sulfadoxine -- -- -- 1 -- -- -- -- -- -- 1 -- 2 Sulfaethoxypyridazine -- 2 -- -- -- -- -- -- -- -- -- -- 2 Sulfamethazine 10 19 3 33 -- 3 4 -- 20 1 -- 3 96 Sulfamethoxazole -- 41 -- -- -- -- -- -- -- -- -- -- Tetracycline -- 2 -- 3 -- -- -- -- -- -- -- -- Tilmicosin 13 9 1 13 -- -- 1 -- -- 3 -- 6 41 5 46 -- 1 -- -- -- -- -- -- -- 2 -- -- 3 Tylosin -- 1 -- -- -- -- -- -- -- -- -- -- 1 Zearalanol -- -- -- -- -- -- -- -- 1 -- -- -- 1 Total 82 371 13 503 1 14 21 3 28 27 78 41 1,182 Chemical Residue Tulathromycin 48 Table 26: 2012 Inspector-Generated Sampling Results: Distribution of Positive Non-Violative Residues by Production Class and Project Name Note: Multiple Positive non-violative residue results may be associated with a single sample (animal) Project Name Production Class Total FAST KIS™ Test COLLGEN SHOW STATE Beef Cows -- 137 -- -- -- 137 Bob Veal -- 366 1 -- -- 367 Bulls -- 22 -- -- -- 22 Dairy Cows -- 587 -- -- -- 587 Formula-Fed Veal -- 8 -- -- -- 8 Goats -- 1 1 -- 1 3 Heavy Calves 7 15 -- -- 1 23 Heifers -- -- -- -- -- 34 Lamb 4 -- -- -- -- 5 Market Swine 20 6 -- 1 -- 27 Non-Formula-Fed Veal -- 59 -- -- -- 59 Roaster Hogs 8 -- -- -- -- 8 Sows 8 5 5 -- -- 13 Steers -- 66 -- -- 1 70 47 1,305 5 1 5 1,363 TOTAL 49 Table 27. 2012 Inspector-Generated Sampling Results: Distribution of Positive Non-Violative Residues by Chemical Residue and Project Name Note: Multiple Positive non- violative residue results may be associated with a single sample (animal) Project Name Chemical Residue Total FAST Ampicillin KIS ™ Test COLLGEN SHOW STATE 37 ------ -- 37 1 18 ---- 3 107 Chlortetracycline 4 13 Danofloxacin ---- 3 107 ------ --- 21 9 --- --- --- 21 9 --- 3 9 --- --- --- 3 9 40 ----- 200 1 Oxytetracycline 8 281 Penicillin 1 154 Pirlimycin --- 11 ---- 5 3 ---------- 40 2 ----- Neomycin ------ Desacetyl Cephaprin Desfuroylceftiofur Cystine Disulfide Dexamethasone Dihydrostreptomycin Enrofloxacin Florfenicol Flunixin Gamithromycin Gentamycin—Sulfate Lincomycin Ractopamine 1 8 1 50 1 8 1 2 201 1 290 ---- 155 11 8 Continued: Table 27. 2012 Inspector-Generated Sampling Results: Distribution of Positive Non-Violative Residues by Chemical Residue and Project Name Note: Multiple Positive non-violative residue results may be associated with a single sample (animal) Project Name Chemical Residue Total FAST KIS ™ Test COLLGEN SHOW STATE Spectinomycin -- 29 -- -- -- 29 Sulfadimethoxine -- 24 -- -- -- 24 Sulfamethazine Tetracycline 1 16 8 160 --- -1 --- 9 177 Tilmicosin -- 31 -- -- -- 31 Tulathromycin -- 70 -- -- -- 70 Tylosin -- 5 -- -- 1 6 UMI 17 73 1 -- 2 93 Total 47 1,305 5 1 5 1,363 51 Chlortetracycline Danofloxacin Desacetyl Cephaprin Desfuroylceftiofur Cystine Disulfide Dexamethasone Dihydrostreptomycin Enrofloxacin Florfenicol Flunixin Gamithromycin Gentamycin—Sulfate Lincomycin Neomycin Oxytetracycline Penicillin Pirlimycin Ractopamine Total Steers Sows Roaster Swine Non Formula Fed Veal Market Swine Lamb Heifer Heavy Calf Goats Dairy Cow Bulls Formula-fed Veal Ampicillin Bob Veal Chemical Residue Beef Cows Table 28: 2012 Inspector-Generated Sampling Results Distribution of Positive but Non-Violative, By Chemical Residues, and Animal Class (Includes FAST and KIS™ Tests) Note: Multiple positive but non-violative residue results may be associated with a single sample (animal) -- -- -- 35 1 -- -- -- -- -- -- -- -- 1 37 -- 4 -- 1 -- -- 1 2 1 -- 2 3 2 2 18 -- -- 1 -- -- -- -- 1 -- -- -- -- -- 1 3 -- -- -- 1 -- -- -- -- -- -- -- -- -- -- 1 5 17 1 82 -- -- -- -- -- -- -- -- -- 2 107 1 -- -4 --- 20 5 --- --- --- --- --- --- --- --- --- --- 21 9 -3 --- --- 2 2 --- --- --- -1 --- 1 -- --- --- --- -3 3 9 1 -- -- 36 -- -- -- 1 -- -- -- -- 1 1 40 2 -- --- --- 2 -- --- --- 1 -- 1 -- --- --- --- --- -1 2 -- 8 -- -- -- -- -- -- -- -- -- 2 -- -- -- -- 1 2 6 124 1 19 2 -- 5 4 -- -- 37 -- -- 3 201 46 142 8 73 -- -- 6 2 3 1 2 1 1 5 290 19 7 -- 125 -- -- -- -- -- -- -- -- 1 3 155 1 5 -- 5 -- -- -- -- -- -- -- -- -- -- 11 -- -- -- -- -- -- -- 1 -- 1 -- -- -- 6 8 52 Chemical Residue Beef Cows Bob Veal Bulls Dairy Cow Formula-fed Veal Goats Heavy Calf Heifer Lamb Market Swine Non Formula -Fed Veal Roaster Swine Sows Steers Total Continued: Table 28. 2012 Inspector-Generated Sampling Results Distribution of Positive but Non-Violative, By Chemical Residue, and Animal Class (Includes FAST and KIS™ Tests) Note: Multiple positive but non-violative residue results may be associated with a single sample (animal) Spectinomycin 1 6 2 19 1 -- -- -- -- -- -- -- -- -- 29 Sulfadimethoxine 3 -- -- 17 -- -- -- -- -- -- 4 -- -- -- 24 Sulfamethazine 3 -- -- 3 -- -- -- -- -- 1 1 -- -- 1 9 Tetracycline 15 43 1 80 4 1 5 2 -- 13 5 1 2 4 177 Tilmicosin 6 -- 2 14 -- -- 1 2 -- -- 1 -- 1 4 31 Tulathromycin 14 -- 4 23 -- -- 2 2 -- -- -- -- -- 25 70 Tylosin 2 1 -- 1 -- -- -- 2 -- -- -- -- -- -- 6 UMI 9 14 2 22 -- 2 2 13 1 8 7 2 4 7 93 Total 137 367 22 587 8 3 23 34 5 27 59 8 13 70 1,363 53 IMPORT RESIDUE REINSPECTION SAMPLING RESULTS Table 29: Samples analyzed under the import reinspection program. Results are presented for imported products subject to normal reinspection. No violations were found in CY 2012. Country Number of nonNumber of Nonviolative Detected positives Number of Violations Number of Exemptions Number of Analyses Argentina 10 0 0 0 10 Australia 133 0 0 26 159 Brazil 45 0 0 8 53 Canada 313 0 0 65 378 Chile 38 0 0 12 50 Costa Rica 63 0 0 4 67 Croatia 1 0 0 0 1 Denmark 25 0 0 2 27 Finland 10 0 0 0 10 France 2 0 0 1 3 Germany 0 0 0 1 1 Honduras 40 0 0 5 45 Ireland 21 0 0 4 25 Israel 7 0 0 0 7 Italy 1 0 0 0 1 117 0 0 76 193 Netherlands 7 0 0 3 10 New Zealand 92 0 0 4 96 Nicaragua 44 0 0 8 52 Northern Ireland 6 0 0 1 7 Poland 8 0 0 4 12 San Marino 1 0 0 0 1 Spain 8 0 0 1 9 United Kingdom 12 0 0 1 13 Uruguay 65 0 0 4 69 TOTAL 1,069 0 0 230 1,299 Mexico 54 Table 30: NRP Import Samples Analyzed, by Country and Animal Class Country Beef Chicken Pork Other *Total* Argentina 10 - - - 10 Australia 115 - - 44 159 Brazil 53 - - - 53 Canada 131 47 114 86 378 Chile 3 7 37 3 50 Costa Rica 67 - - - 67 Croatia - - 1 - 1 Denmark - - 27 - 27 Finland - - 10 - 10 France - - 3 - 3 Germany - - 1 - 1 Honduras 45 - - - 45 Ireland - - 25 - 25 Israel - 3 - 4 7 Italy - - 1 - 1 80 1 102 10 193 Netherlands - - 10 - 10 New Zealand 73 - - 23 96 Nicaragua 52 - - - 52 Northern Ireland - - 7 - 7 Poland - - 12 - 12 San Marino - - 1 - 1 Spain - - 9 - 9 United Kingdom - - 13 - 13 Uruguay 69 - - - 69 Total 698 58 373 170 1,299 Mexico 55 Table 31: Samples analyzed under the import reinspection program, by Chemical Compounds Note: No violations were found in CY 2012. Chemical Residue Antibiotics Arsenic Arsenic & Avermectin Arsenic & Chloramphenicol Avermectin Beta Agonist Chloramphenicol Florfenicol Flunixin Fluroquinolones MRM Pesticides Sulfonamides TOTAL 27 Number of Number of Number of Number of Number of non-violative Exemption Non-Detected Violations Analyses 27 positives 54 0 0 6 60 86 0 0 30 116 21 - - - 21 1 - - - 1 237 0 0 18 255 242 0 0 127 369 15 0 0 3 18 6 0 0 1 7 11 0 0 2 13 0 0 0 1 1 191 - - - 191 90 0 0 15 105 115 0 0 27 142 1,069 0 0 230 1,299 Import products received that were not eligible for sampling; for example processed vs fresh product 56 Table 32: Samples analyzed under the import reinspection program, by chemical compound and animal class. The ‘other*’ category may include lamb, veal, mutton, goat, and turkey. No violations were found. Chemical Residue Beef Chicken Pork Other* Total 17 10 17 16 60 Arsenic - 39 60 17 116 Arsenic and Avermectin 1 - 1 19 21 Arsenic and Chloramphenicol - 1 - - 1 Avermectin 239 - - 16 255 beta-Agonist 104 - 205 60 369 Chloramphenical 1 8 - 9 18 Florfenicol 7 - - - 7 Flunixin 13 - - - 13 Fluroquinolones 1 - - - 1 MRM Pesticides 146 101 - 28 - 17 4 191 105 Sulfonamides 68 - 62 12 142 Total 698 58 373 170 1,299 Antibiotics Table 33: Samples analyzed under the import reinspection program, by chemical compound and product type. Chemical Residue Fresh Processed Total Antibiotics Arsenic Arsenic and Avermectin Arsenic and Chloramphenicol Avermectin beta-Agonist Chloramphenical Florfenicol Flunixin Fluroquinolones Multi-residue method Pesticides Sulfonamides Total 60 106 21 213 352 18 7 13 1 191 105 128 1,215 10 1 42 17 14 84 60 116 21 1 255 369 18 7 13 1 191 105 142 1,299 57 Appendix I FSIS Laboratory Analytical Methods FSIS uses analytical methods to detect, identify, and quantify residues that may be present in meat, poultry, and processed egg products. The Agency uses these methods for monitoring and surveillance activities to determine product adulteration and for human risk assessment evaluations. The Agency uses available methodologies to take appropriate regulatory action against adulterated products in a manner consistent with the reliability of the analytical data. The table below lists the analytical methods and provides links to each method. Compound Aminoglycosides CLG-AMG2 bovine, porcine, poultry Tissue kidney, liver, muscle Antibiotics MLG-34.03 meat and poultry kidney, liver, muscle Avermectins CLG-AVR bovine, porcine, ovine, caprine, equine liver, muscle Beta-Agonists CLGAGON1.03 bovine, porcine, ovine, caprine bovine, porcine liver muscle CLG-RAC1.01 bovine, porcine liver, muscle CLG-BLAC.03 bovine, porcine kidney, muscle Beta-lactams Carbadox Method Species CLG-CBX4 CLGCAM1.02 CLG-CAM.05 beef, poultry, swine beef, poultry muscle muscle Florfenicol CLG-FLOR1 bovine, poultry liver, muscle Flunixin CLG-FLX4.03 Bovine, porcine liver, muscle Fluoroquinolones CLG-FLQ2.00 bovine Macrolides CLG-MAL1.02 beef, pork, poultry Metals CLG-TM3.03 beef, pork, poultry CLG-TM4.01 meat and food products CLG-ARS.04 CLG-MRM 1.02 all animal species, egg products beef, pork liver, muscle kidney, liver, muscle kidney, liver, muscle kidney, liver, muscle kidney, liver, muscle Kidney, muscle Chloramphenicol MRM (multi-residue method) pork liver Nitrofurans CLGNFUR2.01 bovine, porcine, poultry liver Pesticides* CLG-PST5.02 chicken, pork, beef muscle Phenylbutazone CLG-PBZ2.03 beef kidney CLG-SUL porcine, bovine, avian, caprine, ovine, processed products Sulfonamides Tetracyclines CLG-TET2.04 bovine, porcine, ovine poultry Tilmicosin CLG-TIL1.02 bovine Zeranol CLG-ANA.02 ovine, bovine 58 liver, muscle kidney, liver, muscle kidney, muscle kidney, liver, muscle liver, muscle APPENDIX II Statistical Table Table AII indicates the number of samples required to ensure detection of a violation that affects a given percentage of the sampled population. Statistically, for a binomial distribution with sample size “n” and violation rate “v” (in decimal number), if v is the true violation rate in the population and n is the number of samples, the probability, p, of finding at least one violation among the n samples (assuming random sampling) is p = 1-(1-v)n. Therefore, if the true violation rate is 1% (i.e., 0.01), the probabilities of detecting at least one violation with sampling levels of 230 and 300 are 0.90 and 0.95, respectively. On the other hand, if the true violation rate is 0.57% (i.e., 0.0057), the probabilities of detecting at least one violation with sampling levels of 400 and 525 are 0.90 and 0.95, respectively. Similarly, if the true violation rate is 0.29% (i.e., 0.0029), the probabilities of detecting at least one violation with sampling levels of 800 and 1,030 are 0.90 and 0.95, respectively. Table AII. Statistical Table - 2012 National Residue Program Probability (p) of detecting at least Percentage % Violative one violation in (n) samples 0.90 0.95 in the Sample (v) 22 45 230 400 460 800 2,302 4,605 10 5 1 0.57 0.50 0.29 0.10 0.05 29 59 300 525 598 1,030 2,995 5,990 Procedure to calculate the required sample size: 1 − p = (1 − v) n  Subtract one from both side of the equation log(1 − p) = log(1 − v) n  Apply logarithmic function to both side of the equation log(1 − p ) = n * log(1 − v)  A logarithmic function property n= log(1 − p ) log(1 − v)  Sample size based on violation rate (v) and probability of detecting (1-p) 59