U.S. National Residue Program: 2015 Residue Sampling Plans (Blue Book)
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UNITED STATES National Residue Program for Meat, Poultry, and Egg Products 2015 Residue Sampling Plans United States Department of Agriculture Food Safety and Inspection Service Office of Public Health Science March 2015 Table of Contents Table of Contents ............................................................................................................................. ii Preface ............................................................................................................................................ iii Contacts and Comments ................................................................................................................. iii Acknowledgements ......................................................................................................................... iii Principal Authors ............................................................................................................................ iii Acronyms ........................................................................................................................................ iv Introduction ...................................................................................................................................... 1 Overview of the Sampling Plans ...................................................................................................... 5 Domestic Sampling Plan ..................................................................................................... 5 Import Reinspection Sampling Plan ................................................................................... 6 Animal Production Classes ................................................................................................. 7 Summary of the Domestic and Import Reinspection Sampling Plans ............................................. 9 Design of the Domestic Scheduled and Import Reinspection Sampling Plans: Veterinary Drugs, Pesticides, and Environmental Contaminants ........................................... 12 I. Selecting Compounds for Testing ................................................................................. 12 A. Selecting Candidate Veterinary Drugs ............................................................ 12 B. Selecting Candidate Pesticides ........................................................................ 16 C. Selecting Candidate Environmental Contaminants ......................................... 16 II. Prioritizing Candidate Compounds for Testing ............................................................ 18 A. Prioritizing Candidate Veterinary Drugs ........................................................ 18 B. Prioritizing Candidate Pesticides .................................................................... 18 III. Variables for Ranking Domestic Products .................................................................. 19 A. Veterinary Drugs ............................................................................................. 19 B. Pesticides ......................................................................................................... 19 IV. Allocation of Sampling Resources for Veterinary Drugs and Pesticides ................... 21 V. Next Generation Selecting and Ranking Process ......................................................... 22 List of Tables Summary Table I: Production Class by Compound Class, Domestic ............................................ 10 Summary Table II: Production Class by Compound Class, Import ............................................... 10 Summary Table III: Tier II Testing, Domestic .............................................................................. 11 Summary Table IV: Sulfonamide in Imported Processed Product, Domestic ............................... 11 ii Preface The United States National Residue Program (NRP) for Meat, Poultry and Egg Products: Residue Sampling Plans (traditionally known as the Blue Book) summarizes the process of sampling meat, poultry, and egg products for chemical contaminants of public health concern used by the Food Safety and Inspection Service (FSIS). This document details the principles and methods used to plan and design the following NRP sampling plans for: veterinary drugs, pesticides, and environmental contaminants. Explanations are provided with summary tables. The link on page 4 details the FSIS laboratory analytical methods, with species and tissue(s) validated for each method. Contacts and Comments Personnel from the Science Staff (SciS) and the Risk Assessment and Analytics Staff (RAAS), within the Office of Public Health Science (OPHS) at the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) coordinated this effort and are responsible for the publication of this material. Direct questions about the NRP to: USDA/FSIS/OPHS 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: [email protected] 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 Dr. Emilio Esteban, Executive Associate for Laboratory Services; Dr. Pat Basu, Senior Leader – Chemistry, Toxicology, and Related Sciences; Dr. Alice Thaler, Scientific Integrity Officer and Special Assistant to the OPHS Deputy Assistant Administrator; Dr. Michelle Catlin, Director, Risk Assessment and Analytics Staff, and Dr. Patty Bennett, Deputy Director, Science Staff, Mr. Naser Abdelmajid, Statistician, Science Staff, the FSIS Laboratories, the Agency’s Office of Field Operation’s (OFO), Office of Policy and Program Development (OPPD), Office of Data Integration and Food Protection (ODIFP), Office of International Coordination (OIC) and Office of Public Affairs and Consumer Education (OPACE). Furthermore, FSIS would like to acknowledge the members of the Surveillance Advisory Team for their extensive contributions to the planning of the 2015 U.S. National Residue Program. Principal Authors (USDA/FSIS/OPHS) Ms. Margaret O’Keefe Dr. Jorge G. Muñiz Ortiz iii Acronyms 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 FAST – Fast Antimicrobial Screening Test FDA – Food and Drug Administration FSIS – Food Safety and Inspection Service EPA – Environmental Protection Agency HACCP – Hazard Analysis and Critical Control Points IPP – Inspection Program Personnel IRSP – Import Reinspection Sampling Program KIS™ test – Kidney Inhibition Swab Test NASS – National Agricultural Statistics Service NRP – U. S. National Residue Program (Domestic & Import) NSAID – Non-Steroidal Anti-inflammatory Drug OFO – Office of Field Operations OPHS – Office of Public Health Science PHIS – Public Health Information System PHV – Public Health Veterinarian SAT – Surveillance Advisory Team TOI – Types of Inspection iv Introduction The U.S. National Residue Program (NRP) for Meat, Poultry, and Egg Products, administered by the U.S. Department of Agriculture’s (USDA), Food Safety and Inspection Service (FSIS), is an interagency program designed to identify, rank, and test for chemical contaminants in meat, poultry, and egg products. FSIS publishes the NRP 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. 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 NRP’s purpose is to protect the health and welfare of consumers by regulating the meat, poultry, and egg products produced in federally inspected establishments and to prevent the distribution in commerce of any such products that are adulterated or misbranded. The NRP requires the cooperation and collaboration of several agencies for its successful design and implementation. FSIS, along with the Department of Health and Human Services’ (HHS), Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) 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 and Title 40 CFR includes tolerance levels established by EPA. Representatives from FSIS, FDA, EPA, USDA’s Agricultural Research Service (ARS), and the USDA’s Agricultural Marketing Service (AMS), as well as HHS’s Centers for Disease Control and Prevention (CDC), collaborate to develop the scheduled sampling program. These agencies work together to create the annual sampling plan, based on the following: prior NRP findings of chemical residues in meat,