1 CVM Update Comments by Bernadette Dunham, D.V.M., Ph.D. Director, Center for Veterinary Medicine For the Federation of Animal Science Societies Food Safety Symposium, April 28 th 2008, Washington, D.C.
2 Overview CVM Organization Update Animal Cloning Minor Use and Minor Species (MUMS) President s s Budget FY2009 for CVM Animal Drug User Fee Act (ADUFA) Food Safety FDA Amendments Act Animal Feed Safety System (AFSS) Bovine Spongiform Encephalopathy (BSE) Biotechnology Critical Path Initiative National Antimicrobial Resistance Monitoring System (NARMS) White Oak Campus
3 Leadership Change at CVM On January 7 th, 2008 after ~ 14 years as Director of CVM, Dr. Stephen Sundlof was appointed Director of the Center for Food Safety and Applied Nutrition (CFSAN). We expect even stronger ties and collaboration between CFSAN and CVM. There have been a number of other leadership changes within CVM
4 CVM Organizational Chart Office of of the Center Director Bernadette Dunham, D.V.M., Ph.D. Associate Director for Policy and Executive Programs Catherine P. P. Beck Office of of Management Director David E. E. Wardrop, Jr. Jr. Deputy Director Barbara E. E. Leach Deputy Director Gary Gary Claywell Office of of New New Animal Drug Drug Evaluation Office of of Surveillance Office of of Research Director and and Compliance Office of of Minor Uses Uses Director Steven D. D. Vaughn, D.V.M. Director M. and and Minor Species Marleen M. Wekell, Daniel G. G. McChesney, Ph.D. Ph.D. M.S., Ph.D. Animal Drug Drug Development M.S., Ph.D. Deputy Director for for Administration Deputy Director Acting Deputy Director Acting Director David Newkirk, Ph.D. Martine Hartogensis, D.V.M. Michael Thomas Margaret Oeller, D.V.M.
5 CVM Mission CVM is responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. We are developing policies and programs to make safe, effective drugs available. We are using latest science to protect public health.
7 CVM and Animal Cloning In 2001, when it became apparent that animal cloning may become a commercial venture to help improve the quality of herds, FDA requested livestock producers and researchers to keep food from animal clones or their offspring out of the food supply. Since then, FDA has conducted an intensive evaluation that included examining the safety of food from these animals and the risk to animal health. Based on a final risk assessment, a report written by FDA scientists and issued in January 2008, FDA has concluded that meat and milk from cow, pig, and goat clones and the offspring of any animal clones are as safe as food we eat every day.
8 CVM and Animal Cloning The agency is not requiring labeling or any other additional measures for food from cattle, swine, and goat clones, or their offspring because food derived from these sources is no different from food derived from conventionally bred animals. Should a producer express a desire for voluntary labeling (e.g., "this product is clone-free"), it will be considered on a case-by by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading. All of our decisions were based on science, using extensive amounts of data.
9 Minor Use and Minor Species Animal Health Act of 2004 We continue to make progress implementing the MUMS Act. OMUMS has granted 53 designations to date. On February 19, 2008 CVM accepted first Index application. On March 18, 2008, we published a proposed rule on small numbers for the major species. The conditional approval proposed rule is under development.
10 OMUMS Personnel Dr. Meg Oeller is the Acting MUMS Office Director. Dr. Andy Beaulieu continues his involvement. Dr. Joan Gotthardt joined in February 2008 as Director of the Indexing Program. For more MUMS information, go to fda.gov/minortoc.htm Dr. Beaulieu and Dr. Oeller Dr. Gotthardt
11 President s s 2009 Budget General Overview: The President s FY 2009 budget request for CVM totals $ million. Includes $ million in budget authority and $ million in user fees. Program Resource Changes: Ensuring a Strong FDA: +$1,043,000 This initiative will support cost of living pay increases to maintain a professional workforce at the rate of inflation.
12 Budget Food Safety Protecting America s s Food Supply: +$3,043,000 and +9 FTEs This increase is to supply funding to two areas: Prevention: Risk Assessment: +$2,286,000 and 6 FTEs Animal Feed Safety System Processing/Ingredient Standards and Definitions for Animal Feed Feed Labeling Standards Response: Strengthen Emergency Response Infrastructure: $538,000 and 2 FTEs Core Cadre of Scientists to Strengthen Feed Safety Program Risk Communications: +$219,000 and 1 FTE
13 ADUFA Update Animal Drug User Fee Act of 2003 (ADUFA) has been a success. CVM has increased staff to administer the pre-market animal drug evaluation process. We developed new guidances,, policies, and procedures. We have augmented management practices. We have shortened review times (from 295 to 180 days). The public has seen earlier access to safe and effective drugs; industry has seen predictable review times.
14 ADUFA Reauthorization Current program expires September 30, Proposed reauthorization plan: would enhance revenue; would create end-review amendment process ; contains foreign pre-approval inspection provisions; calls for public workshops; and contains plans to develop an electronic submission tool.
15 Additional Performance Goals We will discuss applicable use of pharmacokinetic/pharmacodynamic pharmacodynamic data. We will explore opportunities for early exchange of information about characteristics of a new drug. We will explore shorter review timeframes for the above. We will enhance 2-way 2 way communication to ensure high submission quality.
16 ADUFA Comments FDA sponsored a public meeting about the proposals on March 11, Proposals and process for submitting comments ware explained in February 21, 2008, Federal Register notice. More information is available at: ADUFA proposed language was submitted to the Hill on April 23, 2008 as a must pass piece of legislation.
17 Keeping Food for People and Animals Safe
18 Melamine-Contaminated Pet Food Recall of 2007 Incident brought home importance of safe feed and safe pet food. It had the broadest impact of any food recall in U.S. 19,000 calls to FDA complaint coordinators. FDA had 6.1 million Web site hits. CVM had 1.3 million Web site hits.
19 Big Impact Two suppliers in China shipped melamine contaminated products. Result: the recall hit more than 1,000 products and 60 million servings of pet food recalled. FDA response went beyond pet food to include hog, poultry, and fish feed.
20 Scientific Capabilities We must increasingly rely on our scientific capabilities to uncover problems. Experts used insight, experience to find the cause of disease and death in cats and dogs. Melamine is not known to be toxic. Melamine, combined with cyanuric acid, created crystals that resulted in renal pathology.
21 Crystal Formation Resulted in Renal Pathology Combining melamine, cyanuric acid in laboratory. Crystals form instantly. Melamine cyanurate
22 Importance of Partners FDA relied on its partners during crisis. Companies shared valuable information with us. Groups got information to consumers and other pet food companies. Press helped us get the word out. Partnerships undoubtedly saved many cats and dogs.
23 Food Protection Plan Plan covers products life cycles. The core elements are Prevention Intervention Response
24 Food for People and Animals Food Protection Plan and the Import Safety Action Plan applies to food for people and animals. Center for Veterinary Medicine has responsibility for feed safety. Initiatives underway to address intent of food protection and import safety programs.
25 Feed and Pet Food Industries Increasingly complex, international, and fast-paced industry. Variety of ingredients. Fast product distribution.
26 FDA Amendments Act of 2007 FDAAA legislation (Title X) calls for regulations to establish: ingredient standards and definitions (Sec. 1002); processing standards (Sec. 1002); labeling standards (nutritional and ingredient information) (Sec. 1002(a)(3)). Public meeting planned for May 13 th, Docket is open for FDA to accept comments from individuals, companies, and organizations both domestic and international.
27 Additional Requirements Establish an early warning surveillance and notification system (Sec. 1002(b)) to: identify adulteration and outbreaks of illness; notify veterinarians and stakeholders. Develop and place on the FDA web site a searchable database listing all recalled pet foods. Establish a reportable animal food registry (Sec. 1005). CVM is working closely with CFSAN.
28 Animal Feed Safety System Risk-based prioritization for inspection decisions for deciding what sectors require oversight Extends to ingredients Incorporates counterterrorism concerns
29 Animal Feed Safety System The strengthened AFSS will cover all aspects of feed, including ingredients. It will cover manufacturers, transporters, and distributors. AFSS Team will hold 5 th public meeting on May 14 th, Team will use the meeting to explain more on risk-based approach.
30 Food Safety = Feed Safety Food safety means feed safety: CVM is implementing pet food ingredient safety regulations; CVM is developing a comprehensive feed safety program. Partnerships are key to the success of the Food Protection and Import Safety Action Plans. Applying science and modern technologies will enable us to integrate these plans and keep pace with today s s fast moving food industry.
31 Bovine Spongiform Encephalopathy (BSE) Feed Ban Rule FDA published the final BSE rule on April 25, 2008 in the Federal Register [Vol. 73, No.81 Pg ] 22758] Substances Prohibited From Use in Animal Feed or Food Finalizes the proposed rule issued The final rule becomes effective one year from now on April 27, 2009.
32 BSE Final Rule, cont d The new rule strengthens existing safeguards by prohibiting the use of certain cattle materials in all animal feed, including pet food. The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE.
33 BSE Final Rule, cont d Cattle Material Prohibited in Animal Feed (CMPAF) is material defined as: Brains and spinal cords from cattle 30 mths.. age and older; Entire carcass of cattle not inspected and passed for human consumption unless the cattle are less than 30 mths.. of age, or the brains and spinal cords have been removed; Entire carcass of BSE-positive cattle; Tallow derived from BSE-positive positive cattle or tallow derived from any CMPAF material; and, Mechanically separated beef derived from CMPAF.
34 Cloning Genetic engineering Biotechnology
35 Genetic Engineering Must have government regulation. Consumer concerns, international trade. CVM to facilitate safe, responsible product development. Guidance Document is under development. Regulation of Genetically Engineered (GE) Animals Containing Heritable ndna Constructs. Transgenic cows resistant to mastitis
37 PCR ANALYSIS OF TEST FEED Another example of the advances of biotechnology and its application to real time issues. Percent Bovine MBM* in Dairy Feed 2% 1% 0.5% 0.25% 0.1% 0.05% 0.025% Control MBM - Meat and Bone Meal PCR Polymerase Chain Reaction
38 Using Science to Protect Public Health
39 Critical Path Initiative The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, veterinary drug, biological product, food, or medical device is transformed from a discovery or "proof of concept" into a medical product. For all product areas, the basic idea is to reduce uncertainty about product performance throughout the product life cycle through scientific research. It addresses the lack of regulatory science needed to predict and evaluate product performance. (http:// /initiatives/criticalpath/)
40 CVM Critical Path Projects In 2008 CVM will be involved in: Interrogating Salmonella diversity using microarray technology. Quality by Design for predicting drug release of roller compacted formulations. Characterization of functional analysis of bronchial antimicrobial peptides. Effects of mutation in the multidrug resistance gene 1 (MDR-1) that encodes for P-glycoprotein P in dogs.
41 CVM Critical Path Projects CVM scientists using pharmacogenomics to determine drug safety. They are studying effects of mutation (4 base pair deletion) in the multidrug resistance gene 1 (MDR-1) that encodes for P-glycoprotein P in dogs. Out Membrane In = ATP binding sites Slide Courtesy of Katrina Mealey Out Membrane In P-glycoprotein MDR1 gene = Substrate binding sites P-glycoprotein Mutation
42 MDR-1 1 Gene Mutation Dogs homozygous recessive for this deletion exhibit toxicity (neurotoxicity) to the avermectin class of drugs. Most common in herding dogs. CVM requests, prior to approval, new avermectin products for dogs be tested in ivermectin-sensitive Collies. An understanding of the potential consequences of the MDR-1 1 genetic defect on drug pharmacokinetics should improve the ability of veterinary medicine to predict potential safety and effectiveness concerns in dogs carrying this mutation.
43 Reducing or Eliminating E. coli O157:H7 CVM is working with a number of animal health groups and government partners to identify therapeutic interventions. FDA/CVM is in a position to facilitate evaluation and approval of therapeutic interventions.
44 Challenges Determining how to measure safety and efficacy utilizing critical path tools while still acceptable under our authorizing statutes. Currently working on establishing standards for product effectiveness along with the NCBA, AHI and USDA/APHIS veterinary biologics.
45 National Antimicrobial Resistance Monitoring System Collaborative agreement with USDA, CDC, FDA Test for resistance in these bacteria Salmonella Campylobacter E. coli Enterococcus
46 NARMS The Three Arms FDA/USDA Animal Arm (Clinical & slaughterhealthy animals isolates) FDA/CDC Human Arm (54 participating public health departments submit isolates) FDA/CVM Retail Meat Arm CDC/FoodNet sites
47 Bacteria Tested Human - CDC Non-Typhi Salmonella E. coli 0157:H7 Enterococcus Campylobacter S. Typhi Shigella Listeria Vibrio Animal - USDA Non-Typhi Salmonella E. coli O157:H7 when available Enterococcus Campylobacter Retail meats FDA/CVM Non-Typhi Salmonella E. coli Enterococcus Campylobacter
48 NARMS Program Total number of Salmonella isolates tested, by year and by source. (*2005 and 2006 data are preliminary.) Source * 2006* Humans Chicken Breasts Ground Turkey Ground Beef Pork Chops Chickens Turkeys Cattle Swine Total
49 NARMS Data Available More details and data, including links to CDC and USDA at fda.gov/cvm/narms_pg.html
50 Antimicrobial Resistance Protecting human health through food safety Protecting animal health giving veterinarians the tools they need
51 International Antimicrobial Resistance Work Codex Antimicrobial Resistance Task Force met in Korea in October, It will develop risk analysis guidance to be used in assessing human health risks from resistance. Three working groups established: Risk assessment; Risk profiling (chaired by U.S. government); and Risk management. Next meeting - Brussels the week of May 26, 2008.
52 FDA Campus at White Oak CBER and CVM to join in 2012
53 CVM has had a change in leadership. but we have not changed our openness and willingness to listen to your thoughts and comments. Thank You!
54 CVM Mission - Protecting both Animal Health and Public Health
The National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan 2012-2016 Table of Contents Background... 2 Mission... 3 Overview of Accomplishments, 1996-2011... 4 Strategic Goals and Objectives...
National Antimicrobial Resistance Monitoring System - Enteric Bacteria A program to monitor antimicrobial resistance in humans and animals Antimicrobial resistance in foodborne pathogens is an important
ANIMAL ANTIBIOTICS: Keeping Animals Healthy and Our Food Safe Protecting Animal Health To keep animals healthy, veterinarians and farmers work together to create flock and herd healthmanagement programs
Salmonella and Other Pathogens of Importance in Beef Processing Mindy Brashears, PhD Director-International Center for Food Industry Excellence Department of Animal and Food Sciences Texas Tech University
Agenda Item 5 Conference Room Document 13 FAO/WHO Regional Conference on Food Safety for the Americas and the Caribbean San José, Costa Rica, 6-9 December 2005 THE FOOD SAFETY REGULATORY SYSTEM IN CANADA
BOVINE SPONGIFORM ENCEPHALOPATHY (BSE): REQUIREMENTS FOR THE IMPORTATION OF BEEF AND BEEF PRODUCTS FOR HUMAN CONSUMPTION EFFECTIVE 1 MARCH 2010 Purpose To describe the requirements to safeguard the Australian
Prentice Hall Introduction to Livestock and Companion Animals, Revised 3rd Edition 2009, C O R R E L A T E D T O A. LEADERSHIP 001.00 Demonstrate the major components of leadership involved in successful
This document is scheduled to be published in the Federal Register on 12/16/2015 and available online at http://federalregister.gov/a/2015-31628, and on FDsys.gov Billing Code 3410-DM-P DEPARTMENT OF AGRICULTURE
Healthy California 2020 Initiative: Consensus Building on Top Priority Areas for CDPH Public Health Advisory Committee April 30, 2010 Introducing the CDPH Decision Framework Responding to public health
Have you ever wanted to help animals and people stay healthy? Have you ever thought about working in veterinary medicine? Well, I m here to explain what veterinarians do and answer some of your questions.
Pre-Approval Process INAD vs. NADA Barbara M. Leotta, DVM CVM/ONADE/DTDNFA (240)276-8262 email@example.com Pre-Approval Process General Overview Pathways To Legal Marketing Office of New Animal
Guidance for Industry FDA Export Certificates Submit comments and suggestions regarding this document at anytime to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
FOOD HYGIENE Unit 1: Food Inspection Topic: FOOD SAFETY - A SERIOUS PUBLIC HEALTH ISSUE Lecture 2 Objectives At the end of the session, students should be able to: Discuss the health, social & economic
Performance Audit Health Department Food Protection Program January 2001 City Auditor s Office City of Kansas City, Missouri 03-2001 January 31, 2001 Honorable Mayor and Members of the City Council: This
Course Curriculum for Master Degree in Food Hygiene /Faculty of Veterinary Medicine The Master Degree Food Hygiene /Veterinary Medicine is awarded by the Faculty of Graduate Studies at Jordan University
Animal Sciences 1413 Animal Sciences Center (301) 405-1366 http://www.ansc.umd.edu/ College of Agricultural & Natural Resources Key Features of an Animal Science Major Choose from six different specialties:
Animal Pharming: The Industrialization of Transgenic Animals December 1999 Animal pharming, the process of using transgenic animals to produce human drugs, is staking its claim in a lucrative world market.
Name: Mailing Address: (First) (Last) City: State: Zip/Postal Code: Phone: USDA-APHIS National Veterinary Accreditation Program (NVAP) APHIS-Approved Supplemental Training Materials Order Form Country*
Cornell University Program on Breast Cancer and Environmental Risk Factors in New York State (BCERF) June 2000 Consumer Concerns About Hormones in Food This fact sheet addresses some of the consumer concerns
A Recipe for Safe Food: ISO 22000 and HACCP by John G. Surak Food safety experts insist that the U.S. food supply is one of the safest in the world. However, the Centers for Disease Control and Prevention
Regulation (EU) No 1169/2011 Overview of ongoing and future initiatives Alexandra Nikolakopoulou Deputy Head of Unit E.4, Nutrition, food composition and information Directorate General 13 May 2014, FIC
Animal health requirements for meat and viscera derived from pigs and sausages, ham and bacon made from the said meat and viscera as raw materials to be exported to Japan from Spain Animal health requirements
United States Government Accountability Office Report to Congressional Committees December 2015 INFORMATION TECHNOLOGY FDA Has Taken Steps to Address Challenges but Needs a Comprehensive Strategic Plan
Transcript of FDA Press Conference on the Pet Food Recall March 19, 2007 FTS - HHS FDA Moderator: Cathy McDermott March 19, 2007 9:00 am CT Welcome and thank you for standing at this time operative sence
TITLE 8: AGRICULTURE AND ANIMALS CHAPTER I: DEPARTMENT OF AGRICULTURE : ANIMALS AND ANIMAL PRODUCTS (EXCEPT MEAT AND POULTRY INSPECTION ACT REGULATIONS) PART 30 ANIMAL CONTROL ACT Section 30.10 Definitions
Ministry of Agriculture and Marine Resources MODERNIZATION OF SANITARY AND PHYTOSANITARY LEGISLATION INFORMATION DOCUMENT Introduction The Ministry of Agriculture and Marine Resources received a technical
Issues: Regulatory Obligations Post-marketing Adverse Event Reporting; MDRs and Safety Reports Martha A. Feldman, RAC Drug & Device Development Co., Inc. Topics for today Post-approval requirements for
Partnership for Food Protection (PFP) Strategic Plan FY 2015 through FY 2020 Page 1 of 14 November 19, 2014 Dear Valued Partner: The Partnership for Food Protection (PFP) was established in 2009 to work
ADVICE FOR OWNERS OF PET PIGS AND MICRO PIGS General guidance for keeping your pig ADVICE AND GUIDANCE Keeping pigs or micro pigs animals specially bred to be smaller in adulthood than most other pig species
APHIS Approved Supplemental Training for Accredited Veterinarians has now been approved for Continuing Education Credit by the Texas Board of Veterinary Medical Examiners In the new accreditation process,
Regulatory Submission: Applying GLP in Surgical Efficacy Studies Curtis Schondelmeyer, DVM Director Preclinical Veterinary Services and Efficacy and Surgical Research Services Welcome to Toxikon 2 CONFIDENTIAL
GUIDE FOR FEED MANUFACTURERS TO COMPLY WITH THE FDA FINAL RULE PROHIBITING MAMMALIAN PROTEIN IN RUMINANT FEED Introduction On June 5, 1997, FDA published a final rule prohibiting the use of mammalian protein
Supplemental Training Module 12: Animal Disease Traceability National Veterinary Accreditation Program (NVAP) 1. Print clearly on the sign-in sheets. 2. It is critical that we have your current email address
Journal of Agribusiness 18(1), Special Issue (March 2000):129S133 2000 Agricultural Economics Association of Georgia Food Safety Issues Arising at Food Production in a Global Market Michael P. Doyle Foodborne
Graduate Diploma Program in Veterinary in Livestock Diseases and Health Management International Program (New curriculum 2009) 1. Title of curriculum Graduate Diploma Program in Veterinary in Livestock
Joy Carerra Luba Mad Cow Disease: Bovine Spongiform Encephalopathy Bovine Spongiform Encephalopathy (BSE), otherwise known as Mad Cow, is a fatal disease that affects the central nervous system of cattle.
Veterinary Compounding Veterinarians occasionally use compounded preparations to meet a specific patient s medical need. The purpose of this brochure, created jointly by the Animal Health Institute (AHI),
USDA CSREES Animal Health Programs Update Gary Sherman, MS, DVM, PhD National Program Leader Veterinary Science National Program Leader Veterinary Clinical Medicine, Population Health and Extension (Acting)
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION TRIBAL CONSULTATION POLICY (DRAFT) Table of Contents 1. Background and Purpose 2. Tribal Sovereignty 3. Policy 4. Background on
Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation
Course Curriculum for Master Degree in Veterinary Epidemiology/Faculty of Veterinary Medicine The Master Degree Veterinary Epidemiology/ Faculty of Veterinary Medicine is awarded by the Faculty of Graduate
Regulatory Expectations of Executive Management Steven Lynn, MS, CMQ/OE Director Office of Manufacturing and Product Quality Office of Compliance CDER/US FDA PDA ICH Q10 Executive Management Workshop PDA
1. Basic Certificate in Animal Health and Production (CAHP) NTA Level 4: Modules covered S/N Code Module Name 1. GST 04101 Introduction to Computer 2 GST 04202 Introduction to Sociology and. Communication
Agriculture, Food & Natural Resources Career Cluster Agricultural Animal Production and Management Course Number 01.43200 Course Description: The goal of this course is to provide all students instruction
Safe%Feed/Safe%Food% Overview of Certification Programs: Why Should a Feed Mill Get Certified? Henry Turlington, Ph.D. Director, Quality & Manufacturing Regulatory Affairs American Feed Industry Association
Safe Food for Canadians Act: Legislative and Regulatory Food Safety Modernization in Canada April 10, 2014 Presentation Overview Operating Environment Overview of Legislative and Regulatory developments
SECTION 6 The Codex code of practice on good animal feeding 60 The Codex code of practice on good animal feeding SECTION 6 61 CODE OF PRACTICE ON GOOD ANIMAL FEEDING CAC/RCP 54-2004 SECTION 1. INTRODUCTION
New Florida Cattle Identification Program to Protect Florida s Cattle Industry; Mitigate Spread of Disease Florida Department of Agriculture and Consumer Services Invites Feedback on Draft Rule Over the
Consent MEMORANDUM To: From: Subject: Board of Regents Board Office The Establishment of the Center for Integrated Animal Genomics (CIAG) at Iowa State University Date: September 9, 2002 Recommended Action:
Measuring Food Safety Development of a tool for a general measure for food safety 17-11-2010 Prof. dr. ir. M. Uyttendaele (Sci Com FASFC) Dr. X. Van Huffel, dr. ir. K. Baert, ir. O. Wilmart (FASFC) Terms
Principles of Good Practice for Advertising and Promotion of Animal Health Products A Voluntary Guideline Developed by the Animal Health Institute The Animal Health Institute is the U.S. trade association
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC FSIS DIRECTIVE 5620.1 Rev.1 7/22/14 USING askfsis I. PURPOSE A. This directive provides instruction to inspection
USDA s Mad Cow Disease Surveillance Program: A Comparison of State Cattle-Testing Rates A Report by Public Citizen Health Research Group: www.citizen.org/hrg/ and Critical Mass Energy and Environment Program:
U.S. Food and Drug Administration Protecting the U.S. Food Supply U.S. Department of Health and Human Services What You Need to Know About PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS A Small Entity Compliance
Section 13: Agriculture, Department of Athens and Tifton Veterinary Laboratories The purpose of this appropriation is to provide payment to the Board of Regents for diagnostic laboratory testing, for veterinary
M E A T I N A N I N T E R N A T I O N A L M A R K E T P L A C E U.S. Beef in the International Market Paul Clayton Introduction The international meat market plays an integral role in the total economics
Japan s first Mad Cow Disease Death (Sat 5 Feb) WARM UPS CHAT: Talk in pairs or groups about cows / beef / BSE / CJD / meat / broccoli / human brain / being bedridden / To make things more dynamic, try
US Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines Norman W. Baylor Biologics Consulting Group, Inc. 23-25 June 2014 Foundation Merieux Conference Center OUTLINE OF PRESENTATION Introduction
Multi-locus sequence typing (MLST) of C. jejuni infections in the United States Patrick Kwan, PhD National Campylobacter and Helicobacter Reference Laboratory Enteric Diseases Laboratory Branch Centers
Agricultural Research Clay Center, NE The (USMARC) was authorized by Congress on June 16, 1964, following transfer of the Naval Ammunition Depot from the Department of Defense to the Department of Agriculture.
Connecticut Veterinary Medical Diagnostic Laboratory Department of Pathobiology and Veterinary Science College of Agriculture and Natural Resources University of Connecticut SL Bushmich, MS, DVM CVMDL:
Advances in Meat Research - Volume 10 HACCP in Meat, Poultry and Fish Processing Edited by A.M. PEARSON Courtesy Professor Department of Animal Sciences Oregon State University and T.R. DUTSON Dean, College
Module 7 Overview: Safe Cooking TRAINER: Read this page ahead of time to prepare for teaching the module. PARTICIPANTS WILL: 1. Describe potential hazards of eating food that has not been safely cooked.
Guidance for Industry What You Need To Know About Registration of Food Facilities Small Entity Compliance Guide Additional copies are available from: Office of Compliance, HFS-607 Center for Food Safety
A FDA Perspective on Nanomedicine Current Initiatives in the US Carlos Peña, PhD Office of the Commissioner FDA September 3, 2010 Outline Context Nanotechnology Task Force report summary Identification
QUICK QUIZ ANSWERS MODULE 1 1. An outbreak is an increase in the number of cases of a particular disease greater than is expected for a given time and place. ANSWER:. An outbreak is two or more cases of
Chapter No. 765] PUBLIC ACTS, 2004 1 CHAPTER NO. 765 HOUSE BILL NO. 3229 By Representatives West, Marrero Substituted for: Senate Bill No. 2840 By Senator Cohen AN ACT to amend Tennessee Code Annotated,
Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP U.S. Department of Health and Human Services Food and Drug Administration Center for Drug
[DOCKET NO.96N-0002] DRAFT DRAFT DOCUMENT CONCERNING THE REGULATION OF PLACENTAL/UMBILICAL CORD BLOOD STEM CELL PRODUCTS INTENDED FOR TRANSPLANTATION OR FURTHER MANUFACTURE INTO INJECTABLE PRODUCTS DECEMBER,
Stuffed The Use of Antibiotics and Other Drugs in the U.S. Turkey Industry A report by Food Animal Concerns Trust The Use of Antibiotics and Other Drugs in the U.S. Turkey Industry Stuffed Published 2015
2014 Annual Report on Inspections of Establishments Table of Contents Introduction... 2 Data Collection and Definitions... 3 Section 510(h)(6)(A)(i) Number of Domestic and Foreign Establishments Registered
November 30, 2007 Comments from the National Association of State Public Health Veterinarians (NASPHV) on Proposed Revision of HHS/CDC Animal-Importation Regulations Response to Section 2, Other Animal
SMG 1312.9 FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY OFFICE OF REGULATORY AFFAIRS OFFICE OF OPERATIONS
PRESENCE OF CENTRAL NERVOUS SYSTEM (CNS) TISSUE IN ADVANCED MEAT RECOVERY (AMR) PRODUCTS PRESENCE OF CENTRAL NERVOUS SYSTEM (CNS) TISSUE INTRODUCTION IN ADVANCED MEAT RECOVERY (AMR) PRODUCTS TThe consumption
Salmonella Case Report Modified with permission from a slide set by Bhushan Jayarao Extension Veterinarian Department of Veterinary Science Pennsylvania State University University Park, PA PART ONE Hudson
Quality and Safety Evaluation of Gene Therapy Products in Japan Review Mechanism for Gene Therapy in Japan The review mechanism for gene therapy in Japan was partially amended to simplify the necessary
2015 Government Relations Priorities Each year the United Fresh Produce Association s Board of Directors, Government Relations Council, members and industry partners evaluate and determine the overarching
December 31, 2015 VIA ELECTRONIC SUBMISSION Richard Bailen, MBA, MHA Office of Dietary Supplements National Institutes of Health 6100 Executive Boulevard, Room 3B01 Bethesda, MD 20892-7517 Email: ODS@nih.gov
Office of Acquisitions & Grants Services (OAGS) FDA Small Business Outreach Vendor Fair February 19, 2014 FDA Mission FDA is responsible for: Protecting the public health by assuring that foods are safe,
Brucellosis and tuberculosis A.J. Olivier 2013 Third print 2004 Second print 2002 First print Compiled by Directorate Communication Services in cooperation with ARC-Onderstepoort Veterinary Institute Printed
Youth Pork Quality Assurance Plus Handbook pork.org (800) 456-7675 Youth Handbook - 2 - Introduction Introduction Lesson Objectives Understand each segment s role in the food supply. Identify biological,
A Microbiology Services Company Lab Services Research - Consulting - Regulatory Company description is a microbiology services company specializing in antiinfective discovery and development for the pharmaceutical,
Drug Development & the FDA Pharmacy 309 Tom Hazlet, Pharm.D., Dr.P.H. 616-2732 thazlet@u... Goals & Objectives Be able to describe the major regulatory events in the drug development process the concepts
The Sheep Safety and Quality Assurance Program Melissa Garrod-VanLaningham, DVM THE MISSION OF SSQA Maximize consumer confidence in, and acceptance of, sheep products by using research and education to
SMG 1312.4 FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY OFFICE OF REGULATORY AFFAIRS OFFICE OF OPERATIONS
FRAMEWORK FOR PUBLIC HEALTH GENETICS POLICIES AND PRACTICES IN STATE AND LOCAL PUBLIC HEALTH AGENCIES 1 The mission of public health is to fulfill society s interest in assuring conditions in which people
ANIMAL SCIENCE What can I do with this major? PRODUCTION AND MANAGEMENT Livestock Production: Dairy Cattle, Beef Cattle, Swine, Equine, Sheep, Goat, Poultry Livestock Feed: Production, Development, Quality