Generally Recognized As Safe . . .


WELCOME


Robert S. McQuate, Ph.D.
CEO, Co-Founder
BIOGRAPHY

Bob started his regulatory career within FDA's GRAS Review Branch prior to serving in technical management positions in the private sector with The Dial Company and the National Soft Drink Association. While in the private sector, he addressed numerous high visibility food safety issues including caloric and non-nutritive sweeteners, sulfiting agents, and caffeine. As an independent consultant since 1988, Bob has assisted scores of clients from North America, Asia, and Europe achieve marketplace success for their food products and dietary supplements by fostering the acquisition of the scientific documentation to fulfill the requisite regulatory requirements.

FDA EXPERIENCE
  • Generate regulatory strategies to achieve food ingredient marketplace acceptance for clients.
  • Undertake food ingredient safety assessments, including independent GRAS evaluations in accordance with FDA safety criteria.
  • Interpret FDA Red Book on food additive & GRAS safety evaluations in designing food ingredient testing regimens.
  • Authored food additive petitions & GRAS notifications.
  • Utilize quantitative risk analysis tools on ingredients to ascertain likely risk.
  • Extract present-day and historical consumer exposure information on food ingredients to support client's projected ingredient usage.
  • Assess compositional information on ingredients--including complex naturalproducts--to determine safety influences by various constituents and contaminants.
  • Prepare comprehensive ingredient safety dossiers to support client marketing initiatives.
  • Utilize FDA regulations to guide and support client manufacturing and QA programs.
  • Serve as liaison with FDA on behalf of client interests.
  • Represent client as electronic and print media spokesperson on food safety topics.
  • Undertake critical assessment of regulatory options with recommendations for clients with preparation of white papers.
  • Creatively interpret FDA regulations to favorably impact client business objectives, which included saving one firm $4.2 M per year.
  • Develop proactive regulatory positions to avoid adverse regulatory compliance conditions by drafting client-specific Product Recall Procedures and FDA Inspection Procedures.
  • Aggressive interpretation of scientific documentation to support marketing representations.
RESUME    

Work History

2005 - Present               President & CEO, GRAS Associates, LLC, Bend, OR

1988 - Present               President & CEO, R. S. McQuate & Associates, Inc., Bend, OR

2005 - 2006                    Chemistry Instructor, Truckee Meadows Community College, Reno, NV

2000 - 2005                    Senior Vice President, Scientific & Regulatory Affairs, AminoPath Labs
                                         LLC, Portland, OR

1998 - 2002                    Board Member & Business Consultant, National Institute of Standards &
                                         Technology, Advanced Technology Program, Gaithersburg, MD

1986 - 1996                    Executive Director, Advanced Science & Technology Institute,
                                         Eugene & Corvallis, OR

1991 - 1992                    Adjunct Professor, Food Science & Technology, Oregon State
                                         University, Corvallis, OR

1983 - 1986                    Science Director, National Soft Drink Association, Washington, DC

1980 - 1983                    Senior Regulatory Scientist and Group Leader of Regulatory & Nutrition,
                                          The Dial Company, Inc., Scottsdale, AZ  

1977 - 1980                    Consumer Safety Officer, Food and Drug Administration, Center for
                                          Food Safety & Applied Nutrition, Division of Food and Color Additives,
                                          Washington, DC  

1974 - 1977                    Assistant Professor of Chemistry, Willamette University, Salem, OR

Education

--Postdoctoral Research Fellow with R. G. Wilkins, New Mexico State University, Las Cruces, NM
--Ph.D. in Chemistry, The Ohio State University, Columbus, OH
--B.S. in Chemistry with Honors, Lebanon Valley College, Annville, PA
PROFESSIONAL EXPERIENCE

Consulting Services  --  CEO & Co-Founder, GRAS Associates, LLC.
                                        --  President & CEO, R. S. McQuate & Associates, Inc.
  • Provide broad-based business consulting services to universities and companies involved in technology commercialization.
  • Rapid assimilation of technical and business background for use in formulating commercialization strategies.
  • Critically evaluate new technologies and business plans compared to competitive firms and products for economic potential.
  • Implement marketing activities to establish strategic alliances and/or licensing agreements.
  • Facilitate start-up ventures, including drafting of business plans.
  • Utilize negotiation skills to achieve successful execution of deals.
  • ObtainFDA regulatory clearances and approvals for FDA regulated products and ingredients; develop comprehensive corporate compliance programs.
  • Expert witness and litigation support on food and supplement composition, quality and regulatory matters.
University Experience  --  Executive Director, Advanced Science & Technology Institute

  • Managed industry-university interface program on behalf of University of Oregon, Oregon State University, Oregon Health Sciences University, and Portland State University.
  • Strategic planning and program implementation; managed staff of up to 8.
  • Facilitated linkages between university and research community and private sector, working with over 500 faculty members to yield consulting contracts, industrial research sponsorship, technology licensing and business start-ups.
  • Aggressively marketed faculty expertise, universities' technologies, and research capabilities through network of contacts, internet, publications, and conferences.
  • Represented universities in broad-based statewide and regional economic development initiatives.
                                          --  Faculty, Willamette University, Oregon State University &
                                              Truckee Meadows Community College

  • Presented introductory and upper level chemistry lecture and laboratory courses.
  • Conducted independent research in molecular biology, enzymology, and metal ion catalysis.
  • Generated external grant funding to support six research students and acquire equipment.
  • Provided food safety guidance to industry.
  • Various scientific and chemical education publications.
Private Sector Experience -- Technical Management, The Dial Company & National Soft 
                                                     Drink Association
  • Managed 5-person technical regulatory group with corporate responsibility for compliance with FDA, USDA, EPA, FTC, OSHA, CPSC, and NRC.
  • Creatively interpret regulations to favorably impact company revenues by over $4.2 M annually.
  • Special focus on product and ingredient safety; formulated regulatory strategies in anticipation of and in response to agency positions; applied quantitative risk analysis to product safety considerations.
  • Provided regulatory support and training to Manufacturing and QA on Good Manufacturing Practices requirements.
  • Teamed with Marketing by evaluating advertising, product claims, and labeling for compliance.
  • Assessed university research proposals in response to industry solicitations for funding.
  • Served as liaison for industry interests on food ingredient safety before FDA officials.
  • Served as industry spokesman with media on technical topics such as NutraSweet addition to soft drinks.
Government Experience  --  Staff Scientist, Food & Drug Administration, Business Consultant,
                                                    National Institute of Standards & Technology
  • FDA representative with regulated food industry officials.
  • Managed safety evaluations of food and color additives and GRAS ingredients among FDA scientific divisions and with legal staff.
  • Generated food safety notices, proposals, and regulations.
  • Evaluated complex net weight food labeling and compliance issues and formulated agency position for Commissioner.
  • Participated on special FDA Food Labeling Task Force to develop total food label requirements.
  • Formulated recommended agency policy on iron bioavailability nutritional concerns.
  • Undertake evaluation of industry-generated research proposals for commercialization of advanced technologies with NIST.
  • Served as expert business consultant on NIST Chemistry & Materials Evaluation Board.
  • Chaired 18-person Proposal Evaluation Board in Chemistry & Materials for NIST.

PROFESSIONAL AFFILIATIONS

American Chemical Society                                                               Licensing Executives Society
Institute of Food Technologists                                          Regulatory Affairs Professional Society


BOARD AND COMMITTEE MEMBERSHIPS
  • External Evaluator - Kansas Technology Enterprise Corporation, Higuchi Biosciences Center (2001)
  • Judge - Ohio State University Business Plan Competition (2001)
  • Board of Directors - Universal Pulping, Inc. (1996 - 2004)
  • Scientific Advisory Committee - Bainbridge Technology Group, Ltd. (1991 - 2000)
  • Board of Directors - Regional Council of Project SBIR West (1994 - 1995)
  • Board of Directors - Oregon Environmental Technology Association (1994 - 1995)
  • Co-Director - Oregon Governor's Task Force on Technology Transfer (1991 - 1992)
  • Board of Directors - LEAP, Inc. (1988 - 1994)
  • Board of Directors - Oregon Biosciences Association (1991 - 1993)
  • Board of Directors - BioForum (1988 - 1991)
  • Oregon Governor's Biotechnology Industry Advisory Council (1988)
HONORS, AWARDS AND FELLOWSHIPS
  • Governor Barbara Roberts Certificate of Appreciation - Task Force on Technology Transfer (1993)
  • Governor Neil Goldschmidt Letter of Commendation - Biotechnology Industry Advisory Council (1988)
  • FDA Ward of Merit from FDA Commissioner Jere Goyan (1980)
  • Letter of Commendation from FDA Commissioner Donald Kennedy (1979)
  • Seven Research Grants Awarded as Faculty Member at Willamette University (1974 - 1977)
  • National Science Foundation - Graduate Research Fellowship, The Ohio State University (1971 - 1973)
  • Graduated with Honors, Lebanon Valley College (1969)
  • Petroleum Research Fund - Undergraduate Research Fellowship, Lebanon Valley College (1967 and 1968)
  • Dean's List Student, Lebanon Valley College (1966 - 1969)
  • Salutatorian, South Lebanon High School, Lebanon, PA (1965)
PUBLICATIONS & PRESENTATIONS
Publications:
  •  Hoover, GP, Robinson, EA, McQuate, RS, Schreiber, HD, and Spencer, JN, “Temperature Dependence of the Molar  Absorptivity of the OH Stretching Vibration,” J. Phys. Chem., 73, 4027 (1969).
  •  McQuate, RS and Leussing, DL, “Kinetics and Equilibrium Studies on Formation of Zinc(II)-Salicylaldehyde Schiff Bases Derived from Ethylenediamine and 1,3-Diaminopropane,” J. Am. Chem. Soc., 97, 5117 (1975).
  • McQuate, RS, “Carbonic Anhydrase and Metalloderivatives:  A Bioinorganic Chemistry Study,” J. Chem. Ed., 54, 645 (1977).
  •  McQuate, RS and Reardon, JE, “Kinetics of Formation of Cobalt(II)- and Nickel(II) Carbonic Anhydrase,” J. Chem. Ed., 55, 607 (1978).
  • McQuate, RS, “Acetylacetonate:  Unifying Topic for Inorganic Chemistry Lecture and Laboratory,” Rev. Chilena Educ. Quim., 4, 56 (1979).
  • McQuate, RS, “Federal Regulation of Biotechnology-Derived Foods,” Vectors, 2(2), 4 (1992).
  • McQuate, RS and Kraska, RC, “GRAS Evaluations Facilitate Product Innovation,” Nutrition Business Journal, December 2006, 20-21.
The following documents were authored while with the Food and Drug Administration:
  • “Sodium Thiosulfate; Affirmation of GRAS Status as a Direct and an Indirect Human Food Ingredient,” Fed. Reg., 43, 22937, May 30, 1978.
  • “Bile Salts and Ox Bile Extract; Direct Food Substance Affirmed as Generally Recognized as Safe,” Fed. Reg., 43, 36063, August 15, 1978.
  • “GRAS Status of Lactic Acid and Calcium Lactate,” Fed. Reg., 45, 32324, May 16, 1980.
  • Food Labeling; Net Weight Labeling Requirements,” Fed. Reg., 45, 53023, August 8, 1980.
  • “Sulfiting Agents – Proposed Affirmation of GRAS Status With Specific Limitations; Removal from GRAS Status as Direct
  •  "Human Food Ingredient,” Fed. Reg., 47, 29956, July 9, 1982.
Presentations:
  •  McQuate, RS and Leussing, DL, “Kinetics of Transimination Reactions with Salicylaldehyde Schiff Bases,” Oregon Academy of Sciences, Portland, OR, February 1976.
  • McQuate, RS, Reardon, JE, Aberle, K.L, and Fullmer, SM, “Chemical Dynamics of Nickel(II) Carbonic Anhydrase, Northeast Regional Meeting American Chemical Society, Boston, MA, June 1978.
  • McQuate, RS, “Risk Assessment Applications Mark Beginning of New Era for FDA,” Central Arizona Section American Chemical Society, Phoenix, AZ, March 1981.
  •  McQuate, RS, “What About Aspartame?” Annual Meeting of the Society of Soft Drink Technologists, Phoenix, AZ, April 1984.
  •  McQuate, RS, “Regulatory and Safety Profiles of Non-Nutritive Sweeteners,” Food Regulations and Safety Conference,  Raleigh, NC, June 1984.
  •  McQuate, RS, “Food Labeling and Nutrition Claims:  Tackling the Issues,” Price Waterhouse Executive Forum, Seattle, WA, October 1991.
  •  McQuate, RS, “Commercializing Biotechnology from Oregon Universities,” Pacific Northwest Biotechnology Exposition, Bellevue, WA, September 1992.
  •  McQuate, RS, “Technology Transfer:  New Technologies & Applications,” Annual Meeting of Oregon Environmental Technology Association, Eugene, OR, December 1992.
  •  McQuate, RS, “Rewarding Technology Transfer and Outreach at Universities:  Overcoming Institutional Barriers,” EPA’s Annual Conference of Hazardous Substance Research Centers, Sea Island, GA, November 1994.
  • McQuate, RS, “Technology Transfer for Minority-Owned and Women-Owned Small Businesses,” Battelle Pacific Northwest Technology Transfer Workshop, Portland, OR, April 1995.
  • Kraska, RC and McQuate, RS, “New Thinking on the Scientific Basis of GRAS Determinations,” SupplySide West, Las Vegas, NV, October 2006.
  • Kraska, RC and McQuate, RS, “Submission Requirements:  GRAS Notifications & Food Additive Petitions,” WorldNutra, Reno, NV, November 2006.
  • McQuate, RS and Kraska, RC, “Ensuring Food Ingredient Safety:  Essential Elements of GRAS Determinations,” WorldNutra, Reno, NV, November 2006.

              Robert S. McQuate, CEO & Co-Founder                                                  541-678-5522 
             GRAS Associates, LLC                                              mcquate@gras-associates.com
             20482 Jacklight Lane                                                           www.gras-associates.com
             Bend, OR 97702-3074                                                                         Cell:  541-728-1492
                              Copyright .  GRAS-Associates, LLC.  All rights reserved.  Updated 02/18/09