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Life Sciences Research Office, Inc. (LSRO)

Life Sciences Research Office, Inc. (LSRO). Michael Falk Executive Director. To benefit society by evaluating biological information and scientific opinion for the public and private sectors. Mission. Formed by FASEB in 1962 60’s – 70’s clients: Army, Navy, NASA, FDA 72 – 82 GRAS Reviews

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Life Sciences Research Office, Inc. (LSRO)

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  1. Life Sciences Research Office, Inc.(LSRO) Michael Falk Executive Director

  2. To benefit society by evaluating biological information and scientific opinion for the public and private sectors Mission

  3. Formed by FASEB in 1962 60’s – 70’s clients: Army, Navy, NASA, FDA 72 – 82 GRAS Reviews 80’s – 90’s clients: USDA, FDA, Health Claims 1997 FASEB ASNS 2001 ASNS LSRO, Inc Brief History

  4. Non-profit 501(c)(3) Affiliated with scientific professional societies Independent, objective, respected National, international impact Biomedical, environmental, biological science issues LSRO Inc

  5. American Society for Nutritional Sciences The American Physiological Society The Protein Society American Society for Pharmacology and Experimental Therapeutics American Society for Investigative Pathology The American Society for Bone and Mineral Research The American Society for Clinical Nutrition American College of Nutrition International Society of Regulatory Toxicology and Pharmacology Member Societies

  6. Chair:William Heird, M.D. Baylor College of Medicine Donald Beitz, Ph.D.Iowa State University Sam Enna, Ph.D. University of Kansas Medical Center (ASPET) Arnold Kahn, Ph.D. UC San Francisco (ASBMR) Gilbert Leveille, Ph.D. Cargill, Inc. (ASNS) Robert Newburgh, Ph.D. (The Protein Society) Terry Quill Duane, Morris LLP (ISRTP) Robert Russell, M.D. Tufts University (ASCN) Jacob J. Steinberg, M.D. Albert Einstein College of Medicine (ASIP) Taffy Williams Photogen Technologies, Inc. Board of Directors (2003)

  7. FDA USDA ONR Army Med R &D HHS FAA NASA NIH ASNS Monsanto California Walnut Commission National Dairy Council Calorie Control Council Philip Morris APS/ASPET Patton Boggs Selected Current & Past Clients

  8. Nutrient Requirements for Preterm Infant Formula The Status and Future of Integrative and Organ System Sciences in the U.S. The Adequacy of Existing Scientific Information on Possible Adverse Reactions to Monosodium Glutamate (MSG) Alternative and Traditional Models for Safety Evaluation of Food Ingredients Military Dental Research Review Selected Recent Reports

  9. What We Do • Comprehensive Reviews • ad-hoc Expert Panels • Authoritative Reports • Conferences, Workshops, Symposia • Programmatic and Proposal Peer Review • Scientific Support Services

  10. Policy Regulation Science

  11. General public benefit No product endorsements Fit within our expertise Permit independent action Project Selection Criteria

  12. Recruit the best experts Gather the available information Focus on the essential questions Reports address the contractual charge with transparent reasoning Focus on the science Facilitate the Process

  13. Selected an Expert Panel Conducted a comprehensive literature search Call for public input (Federal Register) Additional public comment (this meeting) Web site Review, rank, and assess the literature Publicly available report Activities

  14. Toxicology Neuro/behavioral tox Pathology Allergy Immunology Pediatrics Developmental tox Reproductive tox Psychology Epidemiology Public health Environmental and occupational health Toxicokinetics Risk assessment Panel Expertise

  15. Federal Register 68: 25047 (5/9/2003) Received 262 submissions 5,096 references Compiled website references Compiled public comments Gathered references Open Meeting 8 speakers Public Comment

  16. Sponsors Statement Dushanka V. Kleinman, D.D.S., M.S.D. (NIDCR, NIH) Mercury Toxicity Boyd E. Haley, Ph.D. (University of Kentucky) Material Properties, Use in Dentistry J. Rodway Mackert, D.M.D., Ph.D.(Med College of Georgia) Clinical Trial Design David C. Bellinger, M.S., Ph.D. (Harvard Med School) Invited Speakers

  17. Sean Delgado Merge Medicine Richard D. Fischer IAOMT Kathryn Chilcote Carol J. Ward DAMS Freya Koss Consumers for Dental Choice Anne Ferreira Charles Brown Consumers for Dental Choice Fred Eichmiller American Dental Assoc. Perspectives on Amalgam Controversy

  18. Keep on schedule Keep on subject (science not policy) Only LSRO & Expert Panel may ask questions Submit all other comments in writing to LSRO Charge to Meeting Participants

  19. Michael Falk, Ph.D. Executive Director, LSRO 301-634-7030 301-634-7876 (fax) falkm@LSRO.org www.LSRO.org

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