FDA & USDA - Food Safety News

October 3 – 4, 2012 • Millennium Knickerbocker Hotel • Chicago, ILFDA & USDAComplianceAn In-Depth and Comprehensive Course on RegulatoryRequirements for the Food and Beverage Industryboot campExpert in-house counsel, regulatory managers and members of the foodregulatory bar will provide a comprehensive overview of the most complex foodlaw and regulations: Product labeling Ingredient approval Marketing and advertising claims Food safety Recalls Natural, organic and GMO productsGain up-to-date regulatory guidance on new food safety requirements post-FSMA:• IMPORTS – how to ensure the safety of your food supply and prepare for expected reform• INSPECTIONS – outlining new Government jurisdiction and authority• FOOD AND ANIMAL FEED – addressing the agricultural use of antibiotics in livestockGain practical tools for addressing day-to-day compliance and regulatorychallenges during the following live mock and interactive sessions:• NEW PRODUCT LAUNCH – how to bring a new food product to market andmeet regulatory requirements across all fronts• RECALLS – how to effectively remove products from the market while avoidingcommon mistakes that can lead to litigation• “OUTSIDE INFLUENCERS” – examining the increasing role of non-governmentalagencies and consumer advocacy groups in fostering food regulation and legislative reform• PREEMPTION – understanding the intersection with the FDA regulatory processand when it is most effective to assert as a theoryInteractive Working Groups • October 2, 2012:FOOD LAW Working Group A – FDA, USDA and FTC Food Law Fundamentals:What Every Food Executive and Attorney Needs to Know about Food Law and RegulationCALIFORNIA Working Group B – Food Counsel’s Guide to Navigating the LegalLandscape in CaliforniaGain firsthand government insights directly fromthe FDA, FSIS, USDA and the FTC on how to:• Structure a complaint food and beverage package label• Craft marketing and advertising claims that will passregulatory scrutiny• Effectively work with government agencies during a recallLisa VolkDirector, Recall Management Staff, Office of Field Inspections,Food Safety Inspection Service, U.S. Department of AgricultureJeff CanavanDeputy Director, Labeling and Program Delivery Division, FSISU.S. Department of AgricultureC. Steven BakerDirector, Midwest Region, Federal Trade CommissionLynn SzybistSupervisor, Labeling Regulations Implementation Team, FoodLabeling and Standards Staff, Office of Nutrition, Labeling &Dietary Supplements, CFSAN, Food and Drug AdministrationBenchmark with your in-house peers on how tonavigate and comply with the complex web ofregulatory and legal requirements for the food andbeverage industry:Beam BrandsClif Bar & CompanyDel Monte FoodsOcean Spray CranberriesMcCain FoodsMeijerSargento FoodsWelch FoodsMedia and Associations Partners:EarnCLECreditsRegister Now • 888-224-2480 • AmericanConference.com/foodbootcamp

Update your food law IQ at ACI’s FDA & USDA Compliance Boot Campand learn how to navigate the complex world of food regulationsFDA...USDA…FTC…all have a hand in the regulation of food products. Each withtheir own set of requirements for food, beverage, poultry, meat and egg products, itis not uncommon for the many agencies involved in the regulation of ‘food’ to haveoverlapping and even conflicting jurisdiction. Making it extremely difficult for the inhousefood lawyer, regulatory, compliance or government affairs executive to keep trackof all the relevant regulatory requirements, one must constantly monitor changes to thelaw governing food products in order to minimize any risk of non-compliance.Learn how to connect the dots of food regulatory law while gaininga clearer understanding of how the FDA, USDA and FTC work togetherto regulate the food industry.Developed specifically to provide a forum for in-house counsel, regulatory, complianceand government affairs executives as well as private practice lawyers to gain acomprehensive overview of food law and regulation, this comprehensive Boot Campwill provide attendees with the ultimate roadmap to navigating the complex world offood regulations.Led by a distinguished faculty comprised of senior-level in-house counsel and foodlaw experts, American Conference Institute’s FDA & USDA Compliance Boot Campwill engage attendees in a deep-dive, two-day examination of food law fundamentals,including an intense exploration of the regulations governing:• Food ingredients and additives• Product labels• Food and beverage marketing and advertising claims• Food safetyAlso get brought up to speed on the current status of proposed and new regulatoryrequirements under FSMA focused on:• Food imports• Inspections• Food and animal feedAn added benefit of attending this event, participants will walk away from this BootCamp with a print copy of all conference materials, including references and copies ofall the key regulations governing food products. Keep this binder as a point of referenceand regulatory guide that can be shared and utilized as an information resource onceback in the office.Optimize your networking opportunities and supplement your training by joining us atone of the Interactive Working Group Sessions:FOOD LAW Working Group A – FDA, USDA and FTC Food Law Fundamentals:What Every Food Executive and Attorney Needs to Know about Food Law andRegulation, From the FDCA to the Lanham Act and Everything In BetweenCALIFORNIA Working Group B – Food Counsel’s Guide to Navigating the LegalLandscape in California: How to Comply with New California-Specific RegulatoryRequirements and Anticipated Legislative Reform while Minimizing Exposure toPrivate LitigationReserve space now for your in-house food lawyer, regulatory or government affairsexecutive or senior associate, junior partner or attorney. Whether you are new to thefood industry or a seasoned professional seeking a comprehensive refresher, you willfind the content of this Boot Camp invaluable for getting up to speed regarding currentfood requirements.Register now by calling 888-224-2480, faxing your registration to 877-927-1563 orregistering online at www.AmericanConference.com/foodbootcamp.Here’s what past attendees of ACI’sFood conferences have to say:“Topics were spot-on, good speakerswith good mix between in-house,government and law firmrepresentation.”- Legal VP–Marketing, PepsiCo“I’d definitely attend another ACIconference. Great conference –excellent content, excellent networking.”- Senior Counsel, ConAgra Foods“Very informative, speakers wereknowledgeable.”- Quality & Sanitation Manager,American Licorice Company“Excellent program; speakers werewell prepared.”“Very good experience.”- Partner, Herrick, Feinstein LLP- Vice President, Tech Sales & General Counsel,Gilster-Mary Lee“Very insightful and relevant to currenttopics I deal with on a daily basis.”- Global Procurement & Distribution Counsel,Whole Foods Market“Very good content. I like theinteraction.”- VP Food & Regulatory Law, Sara LeeA Comprehensive Boot CampDesigned for:Food Manufacturers, Retailers, Distributors,Suppliers, Servers and Restaurants counsel,directors and officers specializing in:• Regulatory Affairs• Government and State Affairs• Legal Affairs• ComplianceAttorneys practicing in the following areasand industries:• FDA Law• Food Law• Food & Beverage• Consumer ProductsRegister now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp

INTERACTIVE WORKING GROUP SESSIONS • October 2, 2012AFOOD LAW WORKING GROUP • 9:00 am – 12:30 pm (Registration Begins at 8:30 am)FDA, USDA and FTC Food Law Fundamentals: What Every Food Executive and Attorney Needs toKnow about Food Law and Regulation, From the FDCA to the Lanham Act and Everything In BetweenMichael RobertsSpecial Counsel, Roll Law Group P.C. (Los Angeles, CA)James F. NealePartner, McGuireWoods LLP (Charlottesville, NC)Do you need an immersion into the nuts and bolts of food law?Not sure of what the applicable regulatory scheme is for a specifictype of food product? Designed to provide attendees with anin-depth primer on food law, including an overview of FDA,USDA and FTC regulations, this interactive working groupsession will engage participants in a comprehensive discussionof the regulatory scheme applicable to food products, includinga discussion of new key provisions under the Food SafetyModernization Act.Whether you are new to the food industry or a seasoned veteranwho is looking to benchmark your knowledge against that ofyour peers, you will find this workshop invaluable for gainingthe background in food law you need to flow seamlessly into theconversations during the main event.Topics to be discussed will include an examination of law applicableto food products specific to the following agencies and regulations:• FDA- Food, Drug, and Cosmetics Act (FDCA)- Fair Packaging and Labeling Act- Food Safety Modernization Act (FSMA)• USDA- Meat, Poultry, and Egg Products Inspection Acts- Egg Products Inspection Act- Federal Meat Inspection Act- Poultry Products Inspection Act• FTC- Federal Trade Commission Act- The Lanham Act• Overview of other laws governing or otherwise impactingthe regulation of food products- Public Health Service Act- Poultry Products Inspection Act- Bioterrorism Act- Sanitary Food Transportation ActBCALIFORNIA WORKING GROUP • 1:30 pm – 5:00 pm (Registration Begins at 1:00 pm)Food Counsel’s Guide to Navigating the Legal Landscape in California: How to Comply withNew California-Specific Regulatory Requirements and Anticipated Legislative Reform while MinimizingExposure to Private LitigationScott T. RickmanAssociate General CounselDel Monte Foods (San Francisco, CA)Trenton H. NorrisPartner & Head, San Francisco and Silicon Valley OfficesArnold & Porter LLP (San Francisco, CA)Proposition 65 and the labeling compliance challenges it presentsare but one of many legal issues currently being faced by foodand beverage manufacturers who sell products in California.Described by many in the industry as one of the most difficultjurisdictions in which to conduct business, it seems each yearthere is a new compliance, legislative or litigation issue rising tothe forefront in California.Beginning with a comprehensive review of the current list ofchemicals regulated by OEHHA under Proposition 65, thenturning to an examination of current legislative proposalsimpacting on food products and finally ending with an analysisof current litigation trends, including consumer fraud and foodborneillness claims, participants in this session will walk awaywith an in-depth knowledge of the current “state of affairs” inCalifornia. Gain practical solutions for how your company canrevise its business practices so as to reduce regulatory exposureand minimize downstream risk to private litigation.Topics to be discussed during this California-focused workinggroup will include:Proposition 65 and Legislative Reform• Overview of how the California ballot process works• Examining the impact on industry of current proposedballot initiatives – GMO, the Green Initiative• Examining the current political landscape and knowing whatreally drives California regulators and consumers to take action• Current trends in proposition 65 enforcement targetingspecific chemicals and updates from OEHHA – 4-MEI,acrlyamide, PhIP, PAHs, benzene, methylmercury, sulfurdioxide, methanol, and lead• Understanding applicable exemptions under Prop 65 andwhen your product may fall within one• How to respond to an enforcement notice and challenge a listing• What to do when an identified carcinogen is naturallyoccurring in your product – is re-formulation an option?• Identifying science and policy-based approaches to mosteffectively prevent a targeted substance from being listed• How to Prop 65-proof your productDefending Against Private Litigation in California• Overview of recent litigation trends in food and beverageproduct litigation in California- food-borne illness – leafy greens, produce- dietary supplement products- consumer fraud –• natural, HFCS, trans fat content, natural and obesity claims• essential nutrients added to food and beverage products– omega-3 fatty acids, probiotics, DHA• overview of contractual claims often tied to consumerfraud litigation implied warranty of merchantability,unjust enrichment- litigation brought in the public interest under Proposition65’s “Bounty Hunter” provision- claims brought under California Business and ProfessionsCode Section 17200• Distinguishing available remedies under the UCL, CLRAand the FAL• Effective defenses – what are they in California?• Summary judgment – can a motion be won in California?• Preemption – overview of recent cases where preemption hasbeen successfully used as a defense in CaliforniaRegister now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp

BOOT CAMP DAY ONE • October 3, 20127:30 Registration and Continental Breakfast8:30 Co-Chairs’ Opening RemarksSarah RollerPartner & Chair, Food & Drug Law PracticeKelley Drye & Warren LLP (Washington, DC)Alana SharenowSenior Corporate CounselOcean Spray Cranberries, Inc. (Lakeville-Middleboro, MA)8:45 How Government Agencies Regulate the FoodIndustry: Deciphering the Jurisdiction, Functions,Organization and Operations of the FDA, USDA,FTC and Other Health Agencies, and How to Stayon Their Good SideAllyson WilcoxAssistant General CounselBeam Brands (Deerfield, IL)Edward ShinSenior Corporate CounselWelch Foods Inc. (Concord, MA)Jolyda O. SwaimPrincipalOlsson Frank Weeda Terman Matz PC (Washington, DC)• Understanding how FDA, USDA, FTC and other stateand federal health agencies intersect and overlap authorityover food products• Deciphering the organizational structure of each agency- FDA – CFSAN (Center for Food Safety and AppliedNutrition)- USDA – FSIS (Food Safety Inspection Service), AMS(Agriculture Marketing Service), APHIA (Animal PlantHealth Inspection Service)- FTC – Bureau of Consumer Protection- CDC, local/state health agencies- TTB (Alcohol and Tobacco Tax and Trade Bureau),Industry Self-Regulation (DISCUS, The Wine Institute,The Beer Institute) with FTC oversight• Defining the scope of each agency’s jurisdiction andauthority and how they intersect- production- importation and wholesale- labeling- marketing and advertising- product recalls• Examining how the agencies exercise their jurisdiction- rule making- product decisions- enforcement• How to work with the agencies and defining policiesand procedures• Recent developments at the FDA, USDA, FTC and TTB10:00 Inside the GRAS Program, Premarket Review andthe Approval Process for Food Additives: How theFDA Determines Food Ingredient ClassificationSarah RollerPartner & Chair, Food & Drug Law PracticeKelley Drye & Warren LLP (Washington, DC)• Distinguishing GRAS classification made through scientificprocedures vs. food additive safety determinations made bya sponsor• When circumstances may give rise to a pre-submissionmeeting with FDA to discuss issues relevant to thesubmission of the GRAS notice• How to outline a substance’s intended condition of usein the food product• Understanding when a GRAS determination can be madebased on “common use in food”• How to structure a response to an FDA response toa GRAS notice10:30 Morning Coffee Break10:45 What’s in a Label? Identifying the CoreComponents of a Compliant Package LabelFOOD LABELINGJeff CanavanDeputy Director, Labeling and Program DeliveryDivision, FSISU.S. Department of Agriculture (Washington, DC)Lynn SzybistSupervisor, Labeling Regulations Implementation TeamFood Labeling and Standards Staff, Office of Nutrition,Labeling & Dietary Supplements, CFSANFood and Drug Administration (College Park, MD)Amy NorrisChief Legal CounselClif Bar & Company (Emeryville, CA)Martin J. HahnPartnerHogan Lovells LLP (Washington, DC)• Understanding the regulatory landscape applicableto food labels- 21 CFR parts 100-199- FDCA Chapter IV- Fair Packaging and Labeling Act of 1966• Distinguishing the role of the FDA and USDA inapproving information listed on a product label- understanding the scope of authority of FSIS and AMSconcerning product labels- distinguishing labels approvable under the prior labelapproval system vs. under generic label approval• Defining the product “label”- front-of-pack, information panel, package insert- label requirements – contents, ingredients, allergens- how to list information posted on website and advertisements• How to avoid allegations of misrepresentation and misbranding• Update on the GMA “Facts up Front” Initiative• Examining FDA and FTC enforcement priorities in foodlabeling: knowing what the enforcement triggers are andhow to avoid themRegister now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp

12:00 Networking Luncheon for Attendees and Speakers1:15 Marketing and Advertising: What Can and CannotBe Said When Crafting Health, Nutrition, Benefit,Function and Mental Performance ClaimsNUTRITION AND HEALTH CLAIMSC. Steven BakerDirector, Midwest RegionFederal Trade Commission (Chicago, IL)Allyson WilcoxAssistant General CounselBeam Brands (Deerfield, IL)Jennifer B. SoussaCounsel, Advertising, Marketing & PromotionsPractice Group, Davis & Gilbert LLP (New York, NY)Product Claims• Delineating the various types of food and beverage productclaims and the regulatory requirements for making each:- nutrient and health – distinguishing NLEA authorizedvs. claims based on an authoritative statement vs.qualified health claims- structure/function – dietary supplements vs. conventionalfoods- mental performance and focus- disease- comparative- calories/ingredients- distinguishing when information provided on a foodproduct label can be classified as “optional information”under 21 CFR 101.81 (d) when making specific healthand disease benefit claims• Distinguishing under what circumstances a health claimthat has been cleared through FDA’s pre-market clearanceprocedures can be deemed:- unauthorized under the FDCA- an unapproved new drug specifically in the contextof disease prevention claimsClaim Substantiation• Identifying what type and quantity of evidence is sufficientto meet FDA and FTC expectations for product claims- scientific evidence and testing required- consumer surveys- taste and internal expert panels- market research firms- clinical studies• Evaluating the evolution of the standard used by FTCto assess claim substantiation• Update on the status of joint enforcement activity in foodand beverage marketing and advertising2:30 Preemption Fundamentals: Overview of RecentCase Decisions and How to Successfully AssertFederal PreemptionMadeleine M. McDonoughPartner & Co-Chair, Agribusiness & Food Safety PracticeShook, Hardy & Bacon L.L.P. (Washington, DC)• Defining express and implied preemption• Understanding the basis for asserting preemption• Recognizing the interplay between preemption and theFDA regulatory process• Examining recent cases where preemption has succeededas a theory – lead, mercury3:00 Afternoon Refreshment Break3:15 Food Safety Modernization Act: Implementation,Timelines & New RequirementsMark CollinsSenior Manager – Regulatory and Consumer AffairsMcCain Foods USA, Inc. (Lisle, IL)Michael MullicanVice President, Assistant General CounselMeijer, Inc. (Grand Rapids, MI)During this practical session, attendees will be brought up tospeed on new and revised requirements under the Food SafetyModernization Act as well as effective and proposed dates forimplementation of key provisions. Learn who will be impactedand when as well as what you need to do now in order to becompliant under:• Title I – prevention of food safety problems• Title II – detection and response to food safety problems• Title III – imported food4:15 MOCK SCENARIO:How to Bring a New Food Product to Market:Best Practices for Ensuring Your Product Complieswith Regulatory Requirements Across all FrontsEdward ShinSenior Corporate CounselWelch Foods Inc. (Concord, MA)Alana SharenowSenior Corporate CounselOcean Spray Cranberries, Inc. (Lakeville-Middleboro, MA)Janet RaddatzVice President – Quality & Food Safety SystemsSargento Foods Inc. (Plymouth, WI)During this session be led through a comprehensive, A to Zdiscussion of the relevant legal, regulatory and complianceconsiderations for bringing a new food or beverage product tomarket. Illustrated through the reference of a brief mock factpattern that will be distributed to attendees on-site, take noteduring this panel as the session leaders guide you through apractical discussion of what boxes to check and in which order.Topics of discussion during this panel will include:• Understanding the regulatory landscape applicable to your“new” product – how requirements vary for food (includingmeat, poultry and egg products) vs. beverage products• Marketing considerations – how to maintain an open lineof communication between marketing and legal whenscreening and developing promotional marketing• How to develop and distinguish your product against:- previous versions of the same product- competitor’s products and claims5:30 Boot Camp Adjourns to Day TwoRegister now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp

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

October 3 – 4, 2012 • Millennium Knickerbocker Hotel • Chicago, IL Interactive Working Group Sessions –October 2, 2012:FDA & USDAComplianceAn In-Depth and Comprehensive Course on RegulatoryRequirements for the Food and Beverage IndustryPRIORITY SERVICE CODE.758L13.INHATTENTION MAILROOM: If undeliverable to addressee, please forward to:Regulatory and Government Affairs, Compliance, Counselboot campFOOD LAW Working Group AFDA, USDA and FTC Food LawFundamentals: What Every Food Executiveand Attorney Must Know about Food Lawand Regulation, From the FDCA to theLanham Act and Everything In BetweenCALIFORNIA Working Group BFood Counsel’s Guide to Navigating theLegal Landscape in California: How toComply with New California-SpecificRegulatory Requirements and AnticipatedLegistlative Reform while MinimizingDownstream Exposure to Private LitigationREGISTRATION FORM Registration FeeThe fee includes the conference‚ all program materials‚ continental breakfasts‚lunches and refreshments.Payment PolicyPayment must be received in full by the conference date. All discounts will beapplied to the Conference Only fee (excluding add-ons), cannot be combinedwith any other offer, and must be paid in full at time of order. Group discountsavailable to individuals employed by the same organization.Cancellation and Refund PolicyYou must notify us by email at least 48 hrs in advance if you wish to senda substitute participant. Delegates may not “share” a pass between multipleattendees without prior authorization. If you are unable to find a substitute,please notify American Conference Institute (ACI) in writing up to 10 daysprior to the conference date and a credit voucher valid for 1 year will be issuedto you for the full amount paid, redeemable against any other ACI conference. Ifyou prefer, you may request a refund of fees paid less a 25% service charge. Nocredits or refunds will be given for cancellations received after 10 days prior tothe conference date. ACI reserves the right to cancel any conference it deemsnecessary and will not be responsible for airfare‚ hotel or other costs incurredby registrants. No liability is assumed by ACI for changes in program date‚content‚ speakers‚ or venue.CONFERENCE CODE: 758L13-CHI YES! Please register the following delegate for the FDA & USDA Boot CampCONTACT DETAILSNAMEAPPROVING MANAGERORGANIZATIONADDRESSPOSITIONPOSITIONCITY STATE ZIP CODETELEPHONEEMAILPAYMENTPlease charge my VISA MasterCard AMEX Discover Card Please invoice meNUMBEREXP. DATECARDHOLDER I have enclosed my check for $_______ made payable toAmerican Conference Institute (T.I.N.—98-0116207)FAXTYPE OF BUSINESS I would like to receive CLE accreditation for the following states: ___________________. See CLE details inside.FEE PER DELEGATE Register & Pay by July 27, 2012 Register & Pay by Aug 29, 2012 Register after Aug 29, 2012 Conference Only $1995 $2095 $2295 Conference & Workshop A or B $2595 $2695 $2895 ELITEPASS*: Conference & Both Workshops $3195 $3295 $3495 I cannot attend but would like information on accessing the ACI publication library and archive*ELITEPASS is recommended for maximum learning and networking value. ACH Payment ($USD)Please quote the name of the attendee(s) andthe event code 758L13 as a reference.For US registrants:Bank Name: HSBC USAAddress: 800 6th Avenue, New York, NY 10001Account Name: American Conference InstituteUPIC Routing and Transit Number: 021-05205-3UPIC Account Number: 74952405Non-US residents please contact Customer Servicefor Wire Payment information✃Hotel InformationAmerican Conference Institute is pleased to offer our delegates a limitednumber of hotel rooms at a preferential rate. Please contact the hotel directlyand mention the “ACI’s FDA & USDA Boot Camp” conference to receive this rate:Venue: Millennium Knickerbocker HotelAddress: 163 East Walton Place, Chicago, Il 60611Reservations: 312-751-8100Incorrect Mailing InformationIf you would like us to change any of your details please fax the label onthis brochure to our Database Administrator at 1-877-927-1563, or emaildata@AmericanConference.com.5 Easy Ways to RegisterMAIL American Conference Institute45 West 25th Street, 11th FloorNew York, NY 10010PHONE 888-224-2480FAX 877-927-1563ONLINE AmericanConference.com/foodbootcampEMAIL CustomerService@AmericanConference.comCONFERENCE PUBLICATIONSTo reserve your copy or to receive a catalog of ACI titles go towww.aciresources.com or call 1-888-224-2480.SPECIAL DISCOUNTWe offer special pricing for groups and government employees.Please email or call for details.Promotional discounts may not be combined. ACI offers financialscholarships for government employees, judges, law students,non-profit entities and others. For more information,please email or call customer service.