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SCIENCE FORUM April 6–9, 2014 Gaylord National Harbor Washington, DC www.GMAScienceForum.com

Program Guide Sponsored By:


PROGRAM GUIDE SCHEDULE AT-A-GLANCE

DETAILED SCHEDULE

Sunday, April 6

Pre-Conference Sessions**

SUNDAY, APRIL 6

7:00 am–5:00 pm

Registration Open

Pre-Conference Sessions

9:00 am–5:00 pm

Pre-conference Sessions

2:00–5:00 pm

Allergen Committee Meeting

7:00 am–5:00 pm Registration Open (Woodrow Wilson Registration Desk) 9:00 am–5:00 pm (Annapolis 1–2)

Monday, April 7 7:00 am–5:00 pm

Registration Open

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

Pre-Conference Session**

JIFSAN Risk Assessment: Enhanced Food Safety Through Risk Analysis Clare 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

Pre-Conference Session**

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

9:00am–12:00 pm (Baltimore 1–2)

12:00–1:45 pm

Keynote Luncheon

2:00–3:15 pm

Concurrent Breakout Sessions

Introduction to Food Law — A Case Study Approach

3:15–3:45 pm

Networking Break

3:45–5:00 pm

Concurrent Breakout Sessions

5:30–6:00 pm

Welcome Reception

6:00–9:30 pm

Annual Conference Gala Dinner

Tuesday, April 8 7:00 am–5:00 pm

Registration Open

7:30–8:30 am

Networking Breakfast with Exhibitors

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Ricardo 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 (Baltimore 3–5)

Pre-Conference Session**

What you MUST Know About the FSMA Proposed Rules in 2014: A Survival Guide Joe 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 Process Manager, Cargill Benjamin Warren, Ph.D., Director, Product Safety & Regulatory Affairs, Land O’Lakes, Inc. MODERATOR: Warren Stone, Senior Director of Science Policy, Compliance and Inspection, GMA

8:45–10:00 am

Concurrent Strategic Issues Sessions

10:00–10:30 am

Networking Break

10:30–11:45 am

Concurrent Strategic Issues Sessions

11:45 am–1:00 pm

Idea Exchange Luncheon

1:15–2:30 pm

Concurrent Breakout Sessions

2:30–3:00 pm

Networking Break

3:00–4:15 pm

Concurrent Breakout Sessions

2:00–5:00 pm (Baltimore 1–2)

GMA Committee Meetings

Regulatory Routes for New Products and Claims

Wednesday, April 9 7:00 am–4:00 pm

Registration Open

7:00–8:00 am

Breakfast on Own

8:00–11:30 am

Concurrent Committee Meetings

1:00–3:30 pm

Concurrent Committee Meetings

Pre-Conference Session**

Donnelly 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

* Invitation Only | ** Separate Fee Required

Allergen Committee Meeting* (Annapolis 3–4)


GMA SCIENCE FORUM

APRIL 6–9, 2014

MONDAY, APRIL 7

Official Science Forum Programming

7:00 am–5:00 pm Registration Open (Woodrow Wilson Registration Desk) 7:30–8:45 am

Welcome Breakfast

(Wilson Ballroom A) Sponsored by: ConAgra, Cargill

Charlie Arnot

CEO, Center for Food Integrity and President CMA

Building Consumer Trust 9:00 am–12:00 pm

Concurrent 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 and the Impact on the Supply Chain (Annapolis 3–4) In light of this evolving international regulatory environment, we will discuss mitigating U.S. customer expectations for FSMA compliance, obligations, contracts and disputes. Keith Mussar, Vice President Regulatory Affairs Chair, Food Committee, I.E.Canada, Canadian Association of Importers and Exporters Thea Emmerling, Minister Counselor, Head of Food Safety, Health and Consumer Affairs, European Union Delegation to the United States

Washington, DC

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 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 M ODERATOR: 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 Obligations and 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 will discuss 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 to amend 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 M ODERATOR: Donna Thede, Ph.D., RD, Director, Global Scientific Affairs, Kellogg Company

Keynote Luncheon

12:00–1:45 pm

(Wilson Ballroom A) Sponsored by: Decernis

9:00–10:15 am

Updating the Nutrition Facts Label (Baltimore 1-2) This session will address key aspects of FDA’s proposed rules to amend 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

Michael R. Taylor, J.D.

Deputy Commissioner for Foods, U.S. Food and Drug Administration

An Update on Food Safety Initiatives

* Invitation Only | ** Separate Fee Required

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GMA SCIENCE FORUM

APRIL 6–9, 2014

Monday, April 7, 2014 (cont.) 2:00–5:00 pm

Concurrent 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 Preventive Controls Proposed Rule Comments (Annapolis 1–2) This session will address how industry currently manages and prevents hazards in a food facility and GMA comments on the Preventive Controls 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 Program Management, GMA 2:00–3:15 pm

Listeria Update and Current Research in 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 leading researchers from academic and government organizations. Richard Brouillette, Food Safety Director, Commercial Food Sanitation 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 4

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 experience with GMOs and pink slime are any indication; we may be in for a bumpy ride. Jack A. Bobo, J.D., M.S., Chief, Biotechnology and Textile Trade Policy Division/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 alternative model testing, in addition to their application regarding regulatory compliance 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 for Risk Assessment (TERA) David Dix, Ph.D., Director, Office of Science Coordination and Policy, U.S. Environmental Protection Agency

Washington, DC

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 Health Assessment Regulatory Sciences & Government Affairs, Dow AgroSciences LLC Thomas Hartung, M.D., Ph.D., Director, Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University 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, Intentional Adulteration. We’ll discuss the difference between mitigation plans and 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 & Scientific Affairs, Cargill Amy Kircher, Ph.D., Director, National Center for Food Protection and Defense, University of Minnesota MODERATOR: Fatemeh Ataei, Manager, Science Program Management, GMA 3:45–5:00 pm

Listeria Update and Current Research in 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 leading researchers 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 of Regulatory Science, Division of Microbiology Tara Smith, R.D., Team Leader, Food Safety Research Information Office, USDA 3:45–5:00 pm

Latin America: Setting the Bar for Anti-Obesity Nutrition Regulation; Managing New Customs Obligations and Responsibilities (Baltimore 1–2) Lisa Gable, President, Healthy Weight Commitment Foundation Lorena 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

* Invitation Only | ** Separate Fee Required


GMA SCIENCE FORUM

APRIL 6–9, 2014

Washington, DC

3:45–5:00 pm

10:30–11:45 am

New Approaches in Toxicology Assessment (cont.)

Prepare for A Recall: A Mock Recall Exercise

(Baltimore 3–5) The presenters will take the audience through new technologies available including Tox21, endocrine disrupting chemicals and alternative model testing, in addition to their application regarding regulatory compliance 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 for Risk 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 Health Assessment Regulatory Sciences & Government Affairs, Dow AgroSciences LLC MODERATOR: Thomas Hartung, M.D., Ph.D., Director, Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University

(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 what considerations should be made when deciding to execute the recall. Ryan Gooley, Recall Consultant, Stericycle ExpertSOLUTIONS Brian Harty, Business Development Manager, Stericycle ExpertSOLUTIONS

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 Washington DC-based musical political satire troupe, Capitol Steps.

TUESDAY, APRIL 8 Official Science Forum Programming 7:00 am–5:00 pm Registration Open (Woodrow Wilson Registration Desk) 7:30–8:30 am

Networking Breakfast with Exhibitors (Wilson Ballroom B,C, and D)

8:45–11:45 am

10:30–11:45 am

Harnessing the Power of Lean Six Sigma 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 positive outcomes 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 at each table so plan to arrive on time for lunch and be prepared to share and learn. 1:15–4:15 pm

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

Concurrent 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’s unique 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

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-state Cyclospora 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 Response and Evaluation Network (CORE), U.S. Food and Drug Administration Kari Irvin, M.S., LCDR, USPHS Commissioned Corps, Response Team 3 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

* Invitation Only | ** Separate Fee Required

5


GMA SCIENCE FORUM

APRIL 6–9, 2014

Tuesday, April 8, 2014 (cont.)

Washington, DC

Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. MODERATOR: George Pugh, Jr., Ph.D., Director, Food Ingredients, The Coca-Cola Company

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 a sustainable diet is and its significance. Robert L. Thompson, Ph.D., Visiting Scholar, The Paul H. Nitze School of Advanced International Studies, Johns Hopkins University Steven B. Mirsky, Ph.D., Research Ecologist, Agricultural Research Service, 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 the Animal Food Proposed Rule (Baltimore 1–2) This session will address key industry concerns and the potential impact 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 Quality Assurance, GMA 1:15–2:30 pm 6

The Fine Print: Need-to-Know Regulations Overshadowed by the Preventive 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 or changes that FSMA has already introduced. Patty Harvey, Director, Enterprise Food Safety & Quality Administration, 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. regulatory actions 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)

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-state Cyclospora outbreak, as well as antimicrobial resistance. Patrick McDermott, M.S., Ph.D., Deputy Director, National Antimicrobial Resistance Monitoring, U.S. Food and Drug Administration 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 School of Advanced International Studies, Johns Hopkins University Steven B. Mirsky, Ph.D., Research Ecologist, Agricultural Research Service, 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 Studies Program, 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 Program Management, GMA 3:00–4:15 pm

The Fine Print: Need-to-Know Regulations Overshadowed by the Preventive 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 Process Authority, Campbell Soup Company MODERATOR : Layne Martin, Manager Process Authority, Research and Development, Hormel Foods Corporation

* Invitation Only | ** Separate Fee Required


GMA SCIENCE FORUM

APRIL 6–9, 2014

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 Drug Administration (FDA) Lynn L. Bergeson, Esq., Managing Partner, Bergeson & Campbell, P.C. MODERATOR: George Pugh, Jr., Ph.D., Director, Food Ingredients, The Coca-Cola Company

Washington, DC

WEDNESDAY, APRIL 9 GMA Committee Meetings 7:00 am–12:00 pm Registration Open (Woodrow Wilson Registration Desk) 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)

Plan now to join us for the

2015 GMA

SCIENCE FORUM April 12–15, 2015 Gaylord National Harbor Washington, DC www.GMAScienceForum.com * Invitation Only | ** Separate Fee Required

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