gaylord national harbor washington, dc … to food law— a case study approach ricardo carvajal,...

P R O G R A M G U I D E

SCIENCE FORUMApril 6–9, 2014Gaylord National Harbor Washington, DC

www.GMAScienceForum.com

CONNECTING SOUND SCIENCE AND RESPONSIBLE SOLUTIONS

Program Guide Sponsored By:

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SCHEDULE AT-A-GLANCESunday, April 6 Pre-Conference Sessions**

7:00 am–5:00 pm Registration Open

9:00 am–5:00 pm Pre-conference Sessions

2:00–5:00 pm Allergen Committee Meeting

Monday, April 7


7:30–8:45 am Conference Welcome and Opening Keynote Speech

9:00–10:15 am Concurrent Signature Sessions

10:15–10:45 am Networking Break

10:45 am–12:00 pm Concurrent Signature Sessions

12:00–1:45 pm Keynote Luncheon

2:00–3:15 pm Concurrent Breakout Sessions

3:15–3:45 pm Networking Break


5:30–6:00 pm Welcome Reception

6:00–9:30 pm Annual Conference Gala Dinner

Tuesday, April 8


7:30–8:30 am Networking Breakfast with Exhibitors

8:45–10:00 am Concurrent Strategic IssuesSessions

10:00–10:30 am Networking Break

10:30–11:45 am Concurrent Strategic IssuesSessions

11:45 am–1:00 pm Idea Exchange Luncheon


2:30–3:00 pm Networking Break


Wednesday, April 9 GMA Committee Meetings


7:00–8:00 am Breakfast on Own

8:00–11:30 am Concurrent Committee Meetings

1:00–3:30 pm Concurrent Committee Meetings

DETAILED SCHEDULE

SUNDAY, APRIL 6Pre-Conference Sessions

7:00 am–5:00 pm Registration Open (Woodrow Wilson Registration Desk)

9:00 am–5:00 pm Pre-Conference Session**(Annapolis 1–2)

JIFSAN Risk Assessment: EnhancedFood Safety Through Risk AnalysisClare Narrod, Ph.D., Risk Analysis Program Lead,

Joint Institute for Food Safety and Applied Nutrition

Robert L. Buchanan, Ph.D., Director, Center for Food Safety and Security Systems

9:00am–12:00 pm Pre-Conference Session**(Baltimore 1–2)

Introduction to Food Law—A Case Study ApproachRicardo Carvajal, M.S., J.D., Director, Hyman, Phelps and McNamara

Diane McColl, Attorney, Hyman, Phelps and McNamara

Devon Hill, Partner, Keller and Heckman, LLP

Riëtte van Laack, Ph.D., J.D., Director, Hyman, Phelps and McNamara

9:00am–12:00 pm Pre-Conference Session**(Baltimore 3–5)

What you MUST Know About the FSMA Proposed Rules in 2014: A Survival GuideJoe Levitt, Esq., Partner, Hogan Lovells and Former CFSAN Director

Tim Jackson, Ph.D., Director of Food Safety, Nestlé USA, Inc

Steve Dawson, Ph.D., Senior Director, Corporate Security, ConAgra Foods

Mark Overland, Director, Global Certifications, Cargill

Rosalind Zils, Global Supplier and External Manufacturer ProcessManager, Cargill

Benjamin Warren, Ph.D., Director, Product Safety & RegulatoryAffairs, Land O’Lakes, Inc.

MODERATOR: Warren Stone, Senior Director of Science Policy,Compliance and Inspection, GMA

2:00–5:00 pm Pre-Conference Session**(Baltimore 1–2)

Regulatory Routes for New Products and ClaimsDonnelly McDowell, J.D., Associate, Kelley Drye & Warren LLP

Justin J. Prochnow, Shareholder, Greenberg Traurig, LLP

Karin A. Gregory, MPH, Partner, Furman Gregory Deptula

MODERATOR: Robert A. Burns, Ph.D., Vice President, Health and Nutrition Policy, GMA

2:00–5:00 pm Allergen Committee Meeting* (Annapolis 3–4)

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* Invitation Only | ** Separate Fee Required

P R O G R A M G U I D E

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MONDAY, APRIL 7Official Science Forum Programming


7:30–8:45 am Welcome Breakfast(Wilson Ballroom A)Sponsored by: ConAgra, Cargill

Charlie ArnotCEO, Center for Food Integrity and President CMA

Building Consumer Trust

9:00 am–12:00 pmConcurrent Signature Issue Sessions

(There will be a Network Break from 10:15–10:45 am in Exhibit Hall.)

9:00–10:15 am

GRAS: Where We Are Today(Annapolis 1–2)

Leaders in the food additive regulation field will provide opinions on opportunities for Generally-Recognized-As-Safe (GRAS) modernization.

Antonia Mattia, Ph.D., Director, DIV Biotechnology and GRAS Notice Review, U.S. Food and Drug Administration

Mitch Cheeseman, Ph.D., Managing Director, Environmental and Life Sciences, Steptoe & Johnson

Ricardo Carvajal, M.S., J.D., Director, Hyman, Phelps and McNamara

Tom Neltner, J.D., Sr. Attorney, NRDC

Tony Pavel, J.D., Partner, Morgan, Lewis and Bockius

Leon Bruner, DVM, Ph.D., Executive Vice President and CSO, Science and Regulatory Affairs, GMA

M ODERATOR: Laurel Fix, Ph.D., DABT, Head of Regulatory Affairs, North America Foods, Unilever

9:00–10:15 am

International Reaction to FSMA andthe Impact on the Supply Chain(Annapolis 3–4)

In light of this evolving international regulatory environment, we willdiscuss mitigating U.S. customer expectations for FSMA compliance,obligations, contracts and disputes.

Keith Mussar, Vice President Regulatory Affairs Chair, FoodCommittee, I.E.Canada, Canadian Association of Importers and Exporters

Thea Emmerling, Minister Counselor, Head of Food Safety, Health andConsumer Affairs, European Union Delegation to the United States

9:00–10:15 am

Updating the Nutrition Facts Label(Baltimore 1-2)

This session will address key aspects of FDA’s proposed rules toamend the Nutrition Facts label and will include topics such as labeling of “added sugars” and changes to serving size (RACC).

Jessica Leighton, Senior Science Advisor, OFVM, FDA

Paula Trumbo, Ph.D., Nutrition Programs, ONLDS, CFSAN, FDA

Jill Kevala, Ph.D., Nutrition Programs, ONLDS, CFSAN, FDA

Sharon Natanblut, Director, Communications, OFVM

MODERATOR: Donna Thede, Ph.D., RD, Director, Global Scientific Affairs,Kellogg Company

10:45 am–12:00 pm

GRAS: Where We Are Today (cont.)(Annapolis 1–2)

Leaders in the field of food additive regulation will provide their opinion on opportunities for generally-recognized-as-safe (GRAS) regulatory modernization, what is broken, what is not and where we go from here.

Antonia Mattia, Ph.D., Director, DIV Biotechnology and GRAS NoticeReview, U.S. Food and Drug Administration

Mitch Cheeseman, Ph.D., Managing Director, Environmental and Life Sciences, Steptoe & Johnson

Ricardo Carvajal, M.S., J.D., Director, Hyman, Phelps and McNamara

Tom Neltner, J.D., Sr. Attorney, NRDC

Tony Pavel, J.D., Partner, Morgan, Lewis and Bockius

MODERATOR: Laurel Fix, Ph.D., DABT, Head of Regulatory Affairs, North America Foods, Unilever

10:45 am–12:00 pm

FSMA and Foreign Suppliers: Managing New Customs Obligationsand Responsibilities(Annapolis 3–4)

In this session, we will discuss the increased customs obligations,options for mitigating those liability risks under the proposed FSVP. In light of this evolving international regulatory environment, we willdiscuss mitigating U.S. customer expectations for FSMA compliance,obligations, contracts, and disputes.

John Brew, Partner, Crowell & Morning

John Fuson, Partner, Crowell & Morning

10:45 am–12:00 pm

Updating the Nutrition Facts Label(Baltimore 1–2)

This session will address key aspects of FDA’s proposed rules toamend the Nutrition Facts label and will include topics such as labeling of “added sugars” and changes to serving size (RACC).

Sarah Roller, Partner, Kelley Drye & Warren LLP

David White, Chief Science Officer, OFVM, FDA

MODERATOR: Donna Thede, Ph.D., RD, Director, Global Scientific Affairs,Kellogg Company

12:00–1:45 pm Keynote Luncheon (Wilson Ballroom A)Sponsored by: Decernis

Michael R. Taylor, J.D.Deputy Commissioner for Foods, U.S. Food and Drug Administration

An Update on Food Safety Initiatives

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GMA SCIENCE FORUM � APRIL 6–9, 2014 � Washington, DC

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Monday, April 7, 2014 (cont.)2:00–5:00 pmConcurrent Breakout Sessions

(There will be a Network Break from 3:15–3:45 pm in Exhibit Hall.)

2:00–3:15 pm

Key Issues from GMA’s PreventiveControls Proposed Rule Comments(Annapolis 1–2)

This session will address how industry currently manages and preventshazards in a food facility and GMA comments on the PreventiveControls for Human Food Proposed Rule.

DeAnn Davis, Ph.D., DABT, Chief Food Safety Officer, Kraft Foods

Ann Boeckman, Chief Counsel, Food Law, Kraft Foods

Maile Hermida, Associate, Hogan Lovells

MODERATOR: Shannon Cooksey, Senior Director, Science ProgramManagement, GMA

2:00–3:15 pm

Listeria Update and Current Researchin Food Microbiology(Annapolis 3–4)

This session will provide an opportunity to learn about the most recent microbial food safety research on various topics by leadingresearchers from academic and government organizations.

Richard Brouillette, Food Safety Director, Commercial FoodSanitation

Martin Wiedmann, Ph.D., Professor of Food Science, Cornell University

MODERATOR: Joseph D. Meyer, Director of Food Safety Microbiology,Covance Laboratories

2:00–3:15 pm

Can Agriculture Save the Planet Before It Destroys It?(Baltimore 1–2)

Social media may determine if agriculture will save the planet by 2050 or destroy it. Science and technology will likely hold the key to getting us where we need to go but, if our media experiencewith GMOs and pink slime are any indication; we may be in for abumpy ride.

Jack A. Bobo, J.D., M.S., Chief, Biotechnology and Textile Trade PolicyDivision/Senior Advisor for Biotechnology, U.S. Department of State

2:00–3:15 pm

New Approaches in Toxicology Assessment(Baltimore 3–5)

The presenters will take the audience through new technologies available including Tox21, endocrine disrupting chemicals and alterna-tive model testing, in addition to their application regarding regulatorycompliance and the selection of less hazardous design strategies.

Thomas Hartung, M.D., Ph.D., Director, Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University

John Reichard, PharmD, Ph.D., Toxicologist, Toxicology Excellence forRisk Assessment (TERA)

David Dix, Ph.D., Director, Office of Science Coordination and Policy, U.S. Environmental Protection Agency

Nicholas Anastas, Ph.D., Green Chemist, Environmental Stewardship,U.S. Environmental Protection Agency (EPA), Region 1 (New England)

Daland Juberg, Ph.D., Fellow, ATS, N.A. Leader, Human HealthAssessment Regulatory Sciences & Government Affairs, Dow AgroSciences LLC


3:45–5:00 pm

New FSMA Proposed Rule: Intentional Adulteration(Annapolis 1–2)

This session will address the impact on the food manufacturers as a result of the newly released FSMA proposed rule, IntentionalAdulteration. We’ll discuss the difference between mitigation plansand contingency plans as part of your food defense program.

Elizabeth Fawell, Associate, Hogan Lovells

Steve Mavity, Senior Vice President, Technical Services, Bumble Bee

Bryan Fort, CPP, Director of Corporate Security, McCormick & Company, Inc.

Joseph Scimeca, Ph.D., Vice President, Global Regulatory & ScientificAffairs, Cargill

Amy Kircher, Ph.D., Director, National Center for Food Protection andDefense, University of Minnesota

MODERATOR: Fatemeh Ataei, Manager, Science Program Management,GMA

3:45–5:00 pm

Listeria Update and Current Researchin Food Microbiology (cont.)(Annapolis 3–4)

This session will provide an opportunity to learn about the most recent microbial food safety research on various topics by leadingresearchers from academic and government organizations.

Padmini Ramachandran, Ph.D., ORISE Fellow, OARSA & CFSAN, U.S. Food and Drug Administration

Tina Lusk, MSPH, Research Microbiologist, FDA/CFSAN, Office ofRegulatory Science, Division of Microbiology

Tara Smith, R.D., Team Leader, Food Safety Research InformationOffice, USDA

3:45–5:00 pm

Latin America: Setting the Bar for Anti-Obesity Nutrition Regulation;Managing New Customs Obligationsand Responsibilities(Baltimore 1–2)

Lisa Gable, President, Healthy Weight Commitment FoundationLorena Cerdan, General Director, ConMexico

Lorena Cerdan, General Director, ConMexico

Carolina Lorduy, Director, FoodIndustry Chamber, Asociación Nacional de Empresarios de Columbia

MODERATOR: Diego Ruiz, Vice President, Global Public Policy and Government Affairs, PepsiCo

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GMA SCIENCE FORUM ● APRIL 6–9, 2014 ● Washington, DC

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3:45–5:00 pm

New Approaches in Toxicology Assessment (cont.)(Baltimore 3–5)

The presenters will take the audience through new technologies available including Tox21, endocrine disrupting chemicals and alterna-tive model testing, in addition to their application regarding regulatorycompliance and the selection of less hazardous design strategies.


John Reichard, PharmD, Ph.D., Toxicologist, Toxicology Excellence forRisk Assessment (TERA)

David Dix, Ph.D., Director, Office of Science Coordination and Policy, U.S. Environmental Protection Agency

Nicholas Anastas, Ph.D., Green Chemist, Environmental Stewardship,U.S. Environmental Protection Agency (EPA), Region 1 (New England)

Daland Juberg, Ph.D., Fellow, ATS, N.A. Leader, Human HealthAssessment Regulatory Sciences & Government Affairs, Dow AgroSciences LLC

MODERATOR: Thomas Hartung, M.D., Ph.D., Director, Center forAlternatives to Animal Testing (CAAT), Johns Hopkins University

5:30–6:00 pm Welcome Reception(Wilson Ballroom B,C, and D)

6:00–9:30 pm Annual Conference Gala Dinner (Wilson Ballroom A)

Networking opportunity and entertainment from WashingtonDC-based musical political satire troupe, Capitol Steps.

TUESDAY, APRIL 8Official Science Forum Programming


7:30–8:30 am Networking Breakfast with Exhibitors (Wilson Ballroom B,C, and D)

8:45–11:45 amConcurrent Strategic Issues Sessions

(There will be a Network Break from 10:00–10:30 am in Exhibit Hall.)

8:45–10:00 am

Food Safety in the Age of the Industrial Internet (Annapolis 1–2) Sponsored by: GE

With disparate machines and vast amounts of operational data, food and beverage manufacturers face industrial big data challenges.Find out how you can set the course to “Do No Harm” with GE’sunique approach, protecting your consumers and your brand.

Richard Carpenter, Chief Technology Strategist, GE Intelligent Platforms

Jeff Bartoletti, Business Unit Leader-Manufacturing, Food Safety, GE Intelligent Platforms

10:30–11:45 am

Prepare for A Recall: A Mock Recall Exercise(Annapolis 3–4) Sponsored by: Stericycle ExpertSOLUTIONS

During this interactive session, attendees have the opportunity to work in small teams to evaluate a mock recall and determine whatconsiderations should be made when deciding to execute the recall.

Ryan Gooley, Recall Consultant, Stericycle ExpertSOLUTIONS

Brian Harty, Business Development Manager, Stericycle ExpertSOLUTIONS

10:30–11:45 am

Harnessing the Power of Lean SixSigma in the Food Testing Laboratory (Annapolis 1–2) Sponsored by: Roka Bioscience

Gain knowledge of Lean Six Sigma (LSS) including key principles and applications, as well as the positiveoutcomes of LSS application in food testing laboratories.

Maureen Harte, Lean Six Sigma Master Black Belt, HartePro Consulting

Brian Van de Water, General Manager, Cherney Microbiology

Andrea McClure, Manager, Nestlé Quality Assurance Center, Nestlé

Scott Hood, Director, Quality and Regulatory Operations, General Mills, Inc.

Gloria Anderson, Director of Customer Relations, Minnesota Valley Testing Laboratory

11:45 am–1:00 pm Idea Exchange Luncheon (Wilson Ballroom A)

Find out what your peers think! Led by subject matter experts serving as table hosts, select from a menu of the hottest topics for an informal peer-to-peer discussion over lunch. Seating is limited ateach table so plan to arrive on time for lunch and be prepared toshare and learn.

1:15–4:15 pmConcurrent Breakout Sessions

(There will be a Network Break from 2:30–3:00 pm in Exhibit Hall.)

1:15–2:30 pm

Emerging Issues in Food Microbiology(Annapolis 1–2)

This session will provide an update on recent and emerging food safety issues. Topics will include FDA CORE and the recent multi-stateCyclospora outbreak, as well as antimicrobial resistance.

David White, Ph.D., Chief Science Officer, U.S. Food and Drug Administration (FDA)

Stelios Viazis, Ph.D., Microbiologist, Coordinated Outbreak Responseand Evaluation Network (CORE), U.S. Food and Drug Administration

Kari Irvin, M.S., LCDR, USPHS Commissioned Corps, Response Team3 Lead, Coordinated Outbreak Response and Evaluation Network(CORE), U.S. Food and Drug Administration (FDA)

MODERATOR: Tim Freier, Ph.D., Director, Global Food Safety Technology, Cargill

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Tuesday, April 8, 2014 (cont.)1:15–2:30 pm

What is a Sustainable Diet and Why Does it Matter?(Baltimore 3–5)

This session will provide insight from an expert panel defining what asustainable diet is and its significance.

Robert L. Thompson, Ph.D., Visiting Scholar, The Paul H. Nitze Schoolof Advanced International Studies, Johns Hopkins University

Steven B. Mirsky, Ph.D., Research Ecologist, Agricultural ResearchService, U.S. Department of Agriculture (USDA)

MODERATOR: Maha Tahiri, Ph.D., Chief Health and Wellness Officer, General Mills

1:15–2:30 pm

Industry’s Key Concerns with theAnimal Food Proposed Rule(Baltimore 1–2)

This session will address key industry concerns and the potentialimpact to human food manufacturers, which diverts product to the animal food supply chain, as a result of the newly released FSMA proposed rule on Preventive Controls for Food for Animals.

Maile Hermida, Associate, Hogan Lovells

David Meeker, Ph.D., MBA, Senior Vice President, Scientific Services,National Renderers Association

Randy Gordon, President, National Grain & Feed Association

Gail Tavill, Vice President, Sustainable Development Research, Quality& Innovation, ConAgra Foods

MODERATOR: Kristen Spotz, Senior Manager, Food Safety and QualityAssurance, GMA

1:15–2:30 pm

The Fine Print: Need-to-KnowRegulations Overshadowed by thePreventive Controls Proposed Rule(Annapolis 3–4)

Most companies are aware of FDA’s new mandatory Recall authority,but they are less familiar with current records access authority orchanges that FSMA has already introduced.

Patty Harvey, Director, Enterprise Food Safety & QualityAdministration, ConAgra Foods

Warren Stone, Senior Director of Science Policy, Compliance and Inspection, GMA

1:15–2:30 pm

CPG/Chemical Emerging Issues(Azalea 1)

The presenters will provide information on the latest U.S. regulatoryactions regarding chemicals in general as well as an update on nanotechnology.

David Prestwood, Director, Federal Affairs, GMA

Treye Thomas, Ph.D., Toxicologist, Office of Hazard Identification and Reduction, Consumer Product Safety Commission (CPSC)

John DiLoreto, President, NanoReg News

Penelope Rice, Ph.D., Toxicologist, Office of Food Additive Safety,Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration (FDA)

Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.

MODERATOR: George Pugh, Jr., Ph.D., Director, Food Ingredients, The Coca-Cola Company

3:00–4:15 pm

Emerging Issues in Food Microbiology(Annapolis 1–2)

This session will provide an update on recent and emerging food safety issues. Topics will include FDA Core and the recent multi-stateCyclospora outbreak, as well as antimicrobial resistance.

Patrick McDermott, M.S., Ph.D., Deputy Director, NationalAntimicrobial Resistance Monitoring, U.S. Food and DrugAdministration

MODERATOR: Tim Freier, Ph.D., Director, Global Food Safety Technology, Cargill

3:00–4:15 pm

What is a Sustainable Diet and Why Does it Matter?(Baltimore 3–5)

David Schmidt, President and Chief Executive Officer, International Food Information Council (IFIC)

Robert L. Thompson, Ph.D., Visiting Scholar, The Paul H. Nitze Schoolof Advanced International Studies, Johns Hopkins University

Steven B. Mirsky, Ph.D., Research Ecologist, Agricultural ResearchService, U.S. Department of Agriculture (USDA)

MODERATOR: Maha Tahiri, Ph.D., Chief Health and Wellness Officer, General Mills

3:00–4:15 pm

Economic Analyses and FDA’s Impact Analysis Comments(Baltimore 1–2)

Richard Bruns, Ph.D., Staff Economist, FDA CFSAN

James Broughel, Ph.D., Program Manager, Regulatory StudiesProgram, Mercatus Center at George Mason University

Jerry Ellig, Ph.D., Senior Research Fellow, Mercatus Center at George Mason University

MODERATOR: Shannon Cooksey, Senior Director, Science ProgramManagement, GMA

3:00–4:15 pm

The Fine Print: Need-to-KnowRegulations Overshadowed by thePreventive Controls Proposed Rule(Annapolis 3–4)

Timothy Haley, Ph.D., Director of Regulatory Affairs, Bush Brothers & Company

Margo Pidgeon, Director of Food Safety, Process Technology, PepsiCo Chicago

Abdulltif Tay, Ph.D., Principal Thermal Processing Specialist, ConAgra Foods

Aakash Khurana, Senior Manager, Process Safety, Aseptic ProcessAuthority, Campbell Soup Company

MODERATOR : Layne Martin, Manager Process Authority, Research andDevelopment, Hormel Foods Corporation


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3:00–4:15 pm

CPG/Chemical Emerging Issues(Azalea 1)

David Prestwood, Director, Federal Affairs, GMA

Treye Thomas, Ph.D., Toxicologist, Office of Hazard Identification and Reduction, Consumer Product Safety Commission (CPSC)

John DiLoreto, President, NanoReg News

Penelope Rice, Ph.D., Toxicologist, Office of Food Additive Safety,Center for Food Safety and Applied Nutrition, U.S. Food and DrugAdministration (FDA)

Lynn L. Bergeson, Esq., Managing Partner, Bergeson & Campbell, P.C.

MODERATOR: George Pugh, Jr., Ph.D., Director, Food Ingredients, The Coca-Cola Company

WEDNESDAY, APRIL 9GMA Committee Meetings


7:00–8:00 am Breakfast on Own

8:00–11:30 am Microbiological Safety Committee Meeting*(Baltimore 3)

Biotechnology Committee Meeting* (Baltimore 2)

PETCO Committee Meeting* (Baltimore 1)

SRAC EC Committee Meeting* (Baltimore 4)

FIAC Share Group Meeting* (Baltimore 5)

10:30 am–2:30 pm SRAC* (Baltimore 4)

1:00–3:30 pm Chemical Management Committee Meeting*(Baltimore 1)

Nutrition Health and Labeling Committee*(Baltimore 2)

RICC Committee Meeting* (Baltimore 3)

Food Defense Committee Meeting* (Baltimore 5)

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Plan now to join us for the

2015 GMA

SCIENCEFORUMApril 12–15, 2015

Gaylord National Harbor Washington, DC

www.GMAScienceForum.com

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gaylord national harbor washington, dc … to food law— a case study approach ricardo carvajal,...

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