FDA & USDA - Food Safety News
FDA & USDA - Food Safety News FDA & USDA - Food Safety News
BOOT CAMP DAY TWO • October 4, 20128:30 Co-Chairs’ Remarks8:35 The Nuts and Bolts of FDA and USDA Food SafetyRegulations: How to Meet Strict Requirements andPrevent Adulteration or ContaminationFOOD SAFETYKim J. WalkerPartner & Leader, National Food and AgricultureIndustry TeamFaegre Baker Daniels LLP (Des Moines, IA)• Defining “adulteration” and “adulterants” under theFDCA and the Federal Meat Inspection Act- poisonous or deleterious substances- added vs. non-added substances- chemical contaminants and carcinogens- filth and extraneous materials- pesticides- metals- STECs – update on new USDA regulation amending theFederal Meat Inspection Act to add six serotypes of E. colito the list of prohibited “adulterants” under the Act• Contrasting allergens and pathogens and understanding thedifference in how the two are regulated by the FDS vs. USDA• How to establish effective food safety guidelines, protocolsand screening measures – traceback, HACCP, sanitationSOPs and testing procedures• Update on the Reportable Food Registry and how the FDAhas used information provided in the Registry to addressfood safety issues9:45 Inspections: Outlining Government Jurisdictionand Authority, How to Prepare and What to Doto Prevent Pitfalls That Can Lead to DownstreamLiability ExposureINSPECTIONSJanet RaddatzVice President - Quality & Food Safety SystemsSargento Foods Inc. (Plymouth, WI)Paul E. BensonChair, Agribusiness, Food & Beverage PracticeMichael Best & Friedrich LLP (Milwaukee, WI)H. Carl MuellerPresidentMueller Communications, Inc. (Milwaukee, WI)Authority and Enforcement• Defining the jurisdiction and authority of each agencyto conduct inspections – FDA, USDA - FSIS, Departmentof Public Health• Addressing “high risk” facility classification• Understanding how the various agencies work together inthe context of inspections – how information is reviewedand filtered?• Outlining the Government’s enforcement powers- recall authority- seizure, injunctions, contempt- understanding when and how the administrativedetention of food can be executed- criminal actions and the Park Doctrine• Addressing “high risk” facility classification• Understanding when and how administrative detentionof food will be executedWhat to Do During and Post-Inspection• Knowing what the Government will be looking for duringan inspection- how to prep your records and employees for an inspection- how to handle a “surprise” inspection- how to respond to agent’s requests on-site- distinguishing a valid investigation from a fishingexpedition and how your staff should react to each• Formulating a Form 483 response post-inspection• How to manage internal and external communicationsand PR associated with a Government inspection• Taking corrective actions post-inspection11:00 Morning Coffee Break11:15 Food Imports: How to Ensure the Safety of YourFood Supply and Comply with Expected Reformunder FSMAFOOD IMPORTSBenjamin L. EnglandFounder & AttorneyBenjamin L. England & Associates, LLCFDAImports.com, LLC (Washington, DC)• Overview of the law regulating food imports and exports –21 U.S.C. 381(a)• Understanding how the FDA, USDA, EPA and Customsmonitor food import/export activity• How to integrate supply chain control into FSMA/VQIPand why it matters• How to take the appropriate steps to insulate your companyfrom liability when importing food products• Suspension of registration and import alerts – examininghow one impacts the otherFood Imports under FSMA Title III• Overview of new programs to be initiated under Title III- foreign supplier verification- third party auditors• Understanding the true timeframe for implementationand what companies can do to minimize liability• Addressing the integration of the HARPC and FSMAprovisions• Importer fees and implications for companies12:15 Networking Luncheon1:30 Update on Food and Animal Feed Reform:Exploring the Current Debate on the AgriculturalUse of Antibiotics in AnimalsKinsey S. ReaganPartnerKleinfeld, Kaplan and Becker, LLP (Washington, DC)• Identifying which antibiotics have been targeted for reformand why- cephalosporins- penicillin- tetracyclineRegister now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp
• Examining the impact on industry of recently-released FDAguidance on agricultural antibiotic use- “The Judicious Use of Medically Important AntimicrobialDrugs in Food-Producing Animals”- antibiotic product labels- Veterinary Feed Directive• Overview of current regulatory proposals under FSMAimpacting on food and animal feed2:00 Understanding the Role of “Outside Influencers”on Food RegulationSarah RollerPartner & Chair, Food & Drug Law PracticeKelley Drye & Warren LLP (Washington, DC)Michael RobertsSpecial CounselRoll Law Group P.C. (Los Angeles, CA)During this panel be engaged in a thought provoking discussionof how quasi- and non-governmental agencies are fosteringthe regulation of the food industry. Utilizing scientific studiesand the initiation of private litigation as a catalyst for bringingregulatory issues to the forefront, more and more oftenregulation and legislation of the food industry at both the stateand federal level is being spawned by actions not generatedwithin a government agency. During this exclusive sessionhear from counsel experienced in working with governmentagencies and private consumer groups as they share with youtheir thoughts into how non-government agencies have beenspurring the government into action.2:45 Afternoon Refreshment Break3:00 MOCK SCENARIO – Recall Management:How to Effectively Oversee a Recall and AvoidCommon Mistakes that Lead to LitigationFOOD RECALLSLisa VolkDirector, Recall Management Staff, Office ofField Inspections, Food Safety Inspection Service,U.S. Department of Agriculture (Washington, DC)Michael MullicanVice President, Assistant General CounselMeijer, Inc. (Grand Rapids, MI)Mark CollinsSenior Manager – Regulatory and Consumer AffairsMcCain Foods USA, Inc. (Lisle, IL)Structured as a step-by-step examination of a mock scenario,this practical panel session will walk you through theexecution of a real-life recall from start to finish. Take noteas you are provided with best practices for efficiently andquickly executing a recall while minimizing your company’sdownstream exposure. Topics of discussion during this sessionwill include:• Tips on how to effectively remove products from themarket place once an issue is discovered – making thedecision when and how to recall• Identifying and correcting regulatory and compliancemishaps that led to the recall• Working with state and federal government to streamlinethe recall process• Maintaining proper documentation during a recall inanticipation of litigation that may result from the recall• Developing a strategy to address publicity issues that ariseas the direct result of a recall4:15 Hot Topics in Food Litigation & EnforcementScott T. RickmanAssociate General CounselDel Monte Foods (San Francisco, CA)Van H. BeckwithPartnerBaker Botts LLP (Dallas, TX)• Overview of highly targeted products for food litigationand enforcement- food-borne illness claims- poultry, produce- food and beverage consumer fraud claims – natural,HFCS, trans fat and obesity claims based on deceptivepackaging and labeling based claims- marketing and advertising claims – claim substantiation• How to minimize litigation exposure arising out ofinteractions with government5:00 Boot Camp ConcludesCONTINUING LEGAL EDUCATION CREDITSCLECreditsAccreditation will be sought in those jurisdictions requested bythe registrants which have continuing education requirements.This course is identified as nontransitional for the purposes ofCLE accreditation.ACI certifies that the activity has been approved for CLE credit by the NewYork State Continuing Legal Education Board in the amount of 16.0 hours.An additional 4.0 credit hours will apply to workshop A/B participation.ACI certifies that this activity has been approved for CLE credit by the StateBar of California in the amount of 13.5 hours. An additional 3.5 credithours will apply to workshop A/B participation.You are required to bring your state bar number to complete the appropriatestate forms during the conference. CLE credits are processed in 4-8 weeksafter a conference is held.ACI has a dedicated team which processes requests for state approval. Pleasenote that event accreditation varies by state and ACI will make every effortto process your request.Questions about CLE credits for your state? Visit our online CLE Help Centerat www.americanconference.com/CLEGLOBAL SPONSORSHIP OPPORTUNITIESWith more than 500 conferences in the United States, Europe, Asia Pacific,and Latin America, American Conference Institute (ACI) provides a diverseportfolio devoted to providing business intelligence to senior decision makerswho need to respond to challenges spanning various industries in the US andaround the world.As a member of our sponsorship faculty, your organization will be deemed asa partner. We will work closely with your organization to create the perfectbusiness development solution catered exclusively to the needs of yourpractice group, business line or corporation.For more information about this program or our global portfolio of events,please contact:Wendy Tyler, Head of Sales, American Conference InstituteTel: 212-352-3220 x5242 | Fax: 212-220-4281w.tyler@AmericanConference.com© American Conference Institute, 2012Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp
- Page 1 and 2: October 3 - 4, 2012 • Millennium
- Page 3 and 4: INTERACTIVE WORKING GROUP SESSIONS
- Page 5: 12:00 Networking Luncheon for Atten
BOOT CAMP DAY TWO • October 4, 20128:30 Co-Chairs’ Remarks8:35 The Nuts and Bolts of <strong>FDA</strong> and <strong>USDA</strong> <strong>Food</strong> <strong>Safety</strong>Regulations: How to Meet Strict Requirements andPrevent Adulteration or ContaminationFOOD SAFETYKim J. WalkerPartner & Leader, National <strong>Food</strong> and AgricultureIndustry TeamFaegre Baker Daniels LLP (Des Moines, IA)• Defining “adulteration” and “adulterants” under theFDCA and the Federal Meat Inspection Act- poisonous or deleterious substances- added vs. non-added substances- chemical contaminants and carcinogens- filth and extraneous materials- pesticides- metals- STECs – update on new <strong>USDA</strong> regulation amending theFederal Meat Inspection Act to add six serotypes of E. colito the list of prohibited “adulterants” under the Act• Contrasting allergens and pathogens and understanding thedifference in how the two are regulated by the FDS vs. <strong>USDA</strong>• How to establish effective food safety guidelines, protocolsand screening measures – traceback, HACCP, sanitationSOPs and testing procedures• Update on the Reportable <strong>Food</strong> Registry and how the <strong>FDA</strong>has used information provided in the Registry to addressfood safety issues9:45 Inspections: Outlining Government Jurisdictionand Authority, How to Prepare and What to Doto Prevent Pitfalls That Can Lead to DownstreamLiability ExposureINSPECTIONSJanet RaddatzVice President - Quality & <strong>Food</strong> <strong>Safety</strong> SystemsSargento <strong>Food</strong>s Inc. (Plymouth, WI)Paul E. BensonChair, Agribusiness, <strong>Food</strong> & Beverage PracticeMichael Best & Friedrich LLP (Milwaukee, WI)H. Carl MuellerPresidentMueller Communications, Inc. (Milwaukee, WI)Authority and Enforcement• Defining the jurisdiction and authority of each agencyto conduct inspections – <strong>FDA</strong>, <strong>USDA</strong> - FSIS, Departmentof Public Health• Addressing “high risk” facility classification• Understanding how the various agencies work together inthe context of inspections – how information is reviewedand filtered?• Outlining the Government’s enforcement powers- recall authority- seizure, injunctions, contempt- understanding when and how the administrativedetention of food can be executed- criminal actions and the Park Doctrine• Addressing “high risk” facility classification• Understanding when and how administrative detentionof food will be executedWhat to Do During and Post-Inspection• Knowing what the Government will be looking for duringan inspection- how to prep your records and employees for an inspection- how to handle a “surprise” inspection- how to respond to agent’s requests on-site- distinguishing a valid investigation from a fishingexpedition and how your staff should react to each• Formulating a Form 483 response post-inspection• How to manage internal and external communicationsand PR associated with a Government inspection• Taking corrective actions post-inspection11:00 Morning Coffee Break11:15 <strong>Food</strong> Imports: How to Ensure the <strong>Safety</strong> of Your<strong>Food</strong> Supply and Comply with Expected Reformunder FSMAFOOD IMPORTSBenjamin L. EnglandFounder & AttorneyBenjamin L. England & Associates, LLC<strong>FDA</strong>Imports.com, LLC (Washington, DC)• Overview of the law regulating food imports and exports –21 U.S.C. 381(a)• Understanding how the <strong>FDA</strong>, <strong>USDA</strong>, EPA and Customsmonitor food import/export activity• How to integrate supply chain control into FSMA/VQIPand why it matters• How to take the appropriate steps to insulate your companyfrom liability when importing food products• Suspension of registration and import alerts – examininghow one impacts the other<strong>Food</strong> Imports under FSMA Title III• Overview of new programs to be initiated under Title III- foreign supplier verification- third party auditors• Understanding the true timeframe for implementationand what companies can do to minimize liability• Addressing the integration of the HARPC and FSMAprovisions• Importer fees and implications for companies12:15 Networking Luncheon1:30 Update on <strong>Food</strong> and Animal Feed Reform:Exploring the Current Debate on the AgriculturalUse of Antibiotics in AnimalsKinsey S. ReaganPartnerKleinfeld, Kaplan and Becker, LLP (Washington, DC)• Identifying which antibiotics have been targeted for reformand why- cephalosporins- penicillin- tetracyclineRegister now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp
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