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Life Sciences Research Office, Inc.(LSRO)

Michael Falk

Executive Director

Mission

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

Brief History

• 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

LSRO Inc

• Non-profit 501(c)(3)

• Affiliated with scientific professional societies

• Independent, objective, respected

• National, international impact

• Biomedical, environmental, biological science issues

Member Societies• 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

Board of Directors (2003)• 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.

Selected Current & Past Clients

• 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 Recent Reports

• 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

What We Do

• Comprehensive Reviews – ad-hoc Expert Panels

• Authoritative Reports

• Conferences, Workshops, Symposia

• Programmatic and Proposal Peer Review

• Scientific Support Services

Policy Regulation

Science

Project Selection Criteria

• General public benefit– No product endorsements

• Fit within our expertise

• Permit independent action

Facilitate the Process

• 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

Activities

• 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

Panel Expertise

• Toxicology• Neuro/behavioral tox• Pathology• Allergy• Immunology• Pediatrics• Developmental tox

• Reproductive tox• Psychology• Epidemiology• Public health• Environmental and

occupational health• Toxicokinetics• Risk assessment

Public Comment• 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

Invited Speakers

• 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)

Perspectives on Amalgam Controversy

• 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.

Charge to Meeting Participants

• Keep on schedule

• Keep on subject (science not policy)

• Only LSRO & Expert Panel may ask questions

• Submit all other comments in writing to LSRO

Michael Falk, Ph.D.

Executive Director, LSRO

301-634-7030

301-634-7876 (fax)

falkm@LSRO.org

www.LSRO.org