The GRAS Associates team is comprised of highly skilled toxicologists, biochemists and regulatory scientists with extensive experience helping clients overcome their most challenging regulatory hurdles.
Dr. Robert S. McQuate, Ph.D., Co-Founder & Senior Vice President, Sales & Business Development
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.
- 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.
Dr. Richard Kraska, Ph.D., DABT, C-Founder, Chief Scientific Officer and Executive Vice President
Rich began his career at FDA in food additives and moved on to GRAS Review. At FDA, he participated in safety evaluations on sensitive topics such as aspartame, cyclamate and salt. For the next twenty-two years he had numerous assignments with three major chemical companies where he integrated critical toxicology aspects into a wide variety of regulatory matters. This included intensive coordination with corporate acquisitions. Since becoming an independent consultant, Rich as helped dozens of clients with product safety and regulatory projects covering food additives, food processing aids, animal feed additives and food packaging materials.
- Assisted FDA General Counsel in deposition of witnesses in lawsuit arising from cyclamate ban
- Reviewed novel studies conducted on aspartame near the end of FDA's review to finalize record and expedited clearance
- Supervised GRAS review of numerous ingredients including salt, caffeine and canola oil
- Managed a wide variety of food additive petitions for indirect and secondary direct uses
- Expert in interpreting FDA indirect additive regulations and applicability between CFR sections
- Construct compliance database for food contact so companies can quickly assess product conformance and organize vendor information
- Assist polymer manufacturers determine biocompatibility of their products for use in medical devices
- interact with Center of Veterinary Medicine on feed additives and residue products for numerous clients
- Consult on all aspects of obtaining and using GRAS status
- Guide numerous clients on FDA regulations for defoamers for use in food processing, paper processing, polymer production and coatings.
- Conduct audits of manufacturing plants for compliance with GMP regulations
- Submitted several food contact notifications, coordinated migration studies and calculated dietary estimates for additives and carcinogenic contaminants