Richard C. Kraska

Generally Recognized As Safe . . .

WELCOME

Richard C. Kraska, Ph.D., DBAT
COO, Co-Founder

BIOGRAPHY

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.

FDA EXPERIENCE

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

SUMMARY OF QUALIFICATIONS

A dynamic, solutions-oriented Toxicology and Regulatory Affairs Consultant with extensive experience working within private industry and government specifically providing broad aspects of expertise within the chemical industry including food additives, foods, food contact materials, cosmetics, lubricants and fuels, coatings, defoamers, anti-microbial pesticides and pharmaceuticals. Additional strengths include:

Toxicology Consulting and Testing
Expert Toxicology Witness and Litigation Support
Product Development
Hazard Assessment and Communication
MSDS Systems/Conversions
Food Additive petitions and Contract Notifications
GRAS Determinations
TSCA and FIFRA Regulations
OSHA, CPSC and FIFRA Labels
Regulatory Audits, Training and Interpretations
Mergers, Acquisitions, Divestitures, Due Diligence
GMP and USDA National Organic Program Reviews
Drug and Device Master File Preparation/Data Development
Trade Association Representation

ACCOMPLISHMENTS

Toxicology Consulting

A voided product recall by managing a toxic contamination through coordination of honest customer communication, contract industrial hygiene and environmental services and manufacturing process change.
Supported successful EPA registration of a fuel product by coordinating $3 million contact testing program.
Met EPA challenge for additional testing on HPV chemicals in a timely matter by organizing competitors into a testing consortium.

Hazard Communication

Overcame chronic MSDS backlog by leading technical team in design and implementation of expert MSDS authoring system that was recognized by a Computerworld Smithsonian Award and has continued to meet company needs for 15 years.
Relieved excessive workload and compliance issues in newly acquired businesses by implementation of corporate MSDS and label system that resulted in efficiencies in several processes at the subsidiaries.
Avoided adverse regulatory guidance from OSHA on products important to a trade association by discussing issue with OSHA staff and being invited to participate in their MSDS advisory panel.

Regulatory Compliance/Affairs/Training

Identified FDA regulatory compliance weaknesses in new acquisitions and through training, audits, GRAS determinations and limited product reformulation these businesses became recognized as leader in compliant products in the marketplace.

Overcame confusion and inefficiency at a "spin off" company by bringing in a subcontractor team to organize regulatory files and review regulatory compliance of the product line. Implemented training on a database for all newly hired staff.

Assisted the legal division in training new environmental attorneys after a merger by conducting training and discussion sessions on aspects of FDCA, TSCA, OSHA, FIFRA and global which led to identifying critical issues and establishing a good working relationship between attorneys and compliance staff.

WORK EXPERIENCE

2005 - Present          Chief Operating Officer, GRAS Associates, LLC, Bend, OR

2004 - Present          Kraska Consultants, Inc., Bonita Springs, FL, Vice President and Principal

1987 - 2004               The Lubrizol Corporation, Wickliffe, OH - Manager, Special Toxicology and
                                     Regulatory Projects (2001-2004), Manager, Toxicology and Risk
                                   Assessment (1987-2001)

1985 - 1987               BP America Inc. (formerly The Standard Oil Co.), Cleveland, OH - Manager,
                                  Product Safety and Regulatory Compliance

1983 - 1985               American Cyanamid Company, Chemicals Group, Wayne, NJ - Manager,
                                  Toxicology Programs

1981- 1983                Food and Drug Administration - Washington, DC, GRAS Review Branch,
                                  Division of Food and Color Additives, Supervisory Consumer Safety Officer,
                                  Petitions Control Branch, Division of Food and Color Additives, Consumer
                                  Safety Officer

EDUCATION / CERTIFICATIONS

--Diplomat, American Board of Toxicology
--Ph.D., Pharmacology, University of Minnesota
--B.S., Chemistry, Providence College

PUBLICATIONS / PRESENTATIONS

2 Chapters (Chemical Control Laws, Hazard Communication) in Regulatory Toxicology, First Edition, Raven Press, 1995, Second Edition, Taylor and Francis, 2001, HPV Toxicology Testing, Risk Assessment and Risk Management.

Lubricant Additive Safety, Trade Association Environmental Activism, Product Deselection Lists, Automated MSDS Systems, Confidential Business information under TSCA, TSCA Section 12(b) Compliance.

TRAINING / COURSE PRESENTATIONS

     General Regulatory Overview               FDA Food Additive and Food Contact Regulations
    Hazard Communication                        TSCA Comprehensive Compliance Training
                                                                     Product Regulatory Law Course (TSCA, FDCA, OSHA)

PROFESSIONAL AFFILIATIONS

Chemical Reporting Task Group, Chemical Manufacturers Association (1983-1998), Chairperson (1997-1998)

Safety, Health, Environmental and Regulatory Affairs Committee, Independent lubricant Manufacturers Association (1997 to present), Vice Chairperson (2002-2003), Chairperson (2004)

Oversight Committee, Metalworking Fluid Product Stewardship Group, Independent Lubricant Manufacturers Association (1997-2004)

Health, Environmental and Regulatory Task Group, Petroleum Additives Panel (1997-2002)

Chairperson, Sensitization Work Group (1999-2002)

Biocides Panel, AEATF II Protocol Committee and Technical Committee (2003-2004)

Richard C. Kraska, Ph.D., DABT, COO & Co-Founder 216-470-7280 GRAS Associates, LLC kraska@gras-associates.com
Bonita Springs, FL 34135 www.gras-associates.com