Regulatory Expert in the Fields of Food and Feed Additive Safety Assessment, GRAS Notifications, Food Additive Petitions, Quality, Hazard Analysis and Good Manufacturing Practice

Expertise

• Regulatory support in the fields of food and feed additive safety assessment, GRAS notifications, food additive petitions, quality, hazard analysis and good manufacturing practice.
• GRAS Notifications for CFSAN and CVM, and FSMA compliance.
• Broad knowledge of the fermentation-derived enzyme, food ingredient, food and feed additive, and dairy culture fields.
• Additive, ingredient or product safety assessment, preparation and submission of GRAS notifications or additive petitions and in shepherding submissions through the filing process.
• As a Regulatory Professional; active in the Enzyme Technical Association, worked with AAFCO and AFIA, FDA's Center For Food Safety and Applied Nutrition, (CFSAN) Center for Veterinary Medicine (CVM), California State Department of Agriculture, as well as numerous counterparts of these agencies in Canada, Europe, Scandinavia, Asia, Australia, Mexico and South America.

Experience

Independent Consultant, Present

Genencor International, Inc. Director, Regulatory Affairs, 1990 - 2003

• Manage product safety and regulatory compliance.
• Manage the development of toxicology strategy, product safety assessments, plant good manufacturing and sanitation compliance and plant sanitation strategies.
• Prepare and submit GRAS petitions and notifications, food and feed additive submissions
• Developed and led the implementation of a Total Quality Management culture worldwide, resulting in successful team, project and meeting management strategies company-wide.

Accomplishments

• Successfully filed, or participated in filing GRAS listing or GRAS notifications for the following food and/or feed enzyme products and associated chemical components, including:
• Immobilized Glucose Isomerase derived from S. olivaceus and Immobilizing chemicals.
• As part of ETA at Miles/Bayer and at Genencor International, Inc., participated in various actions relating to the GRASP 3G0016 enzyme, GRAS petition and subsequent filings, resulting in the GRAS notice for the subject enzyme preparations.
• Prepared or participated in the filing of numerous GRAS Notices for food use enzyme preparations with FDA CFSAN.
• Worked with FDA's CVM and AAFCO to develop AAFCO's enzyme marketing coordination document.
• Worked with Health Canada and ETA in helping to forge regulations for food and feed enzymes in Canada.
• Led the regulatory aspects of commercialization of numerous proprietary food, feed and industrial enzyme preparations.
• Implemented a Good Manufacturing Practice (GMP) policy, trained plant personnel at all Genencor plants worldwide and served as primary internal auditor to assure compliance with GMP in all plants and, where appropriate, incorporated Hazard Analysis Critical Control Point (HACCP).
• Introduced and led implementation of a Total Quality Management (TQM) strategy and culture within Genencor worldwide.
• Trained and facilitated project teams and natural work groups in various locations resulting in superior team function and successful project outcomes.
• Developed products and raw materials regulatory database, capturing the regulatory status of products, raw materials and ingredients for Genencor's product lines worldwide.

Haarmann & Reimer, (Bayer GmbH Subsidiary), 1960 - 1990

• Serving the positions: Manager, Regulatory Affairs, Product Safety and Decision Support.
• Responsible to Director, Regulatory Affairs and Vice President, Research and Development for monitoring regulatory compliance, submissions, GRAS determinations and production plant Good Manufacturing Practice (GMP) and sanitation.
• Oversaw the safety determination process for new products, new product uses and materials and additives used in their production.
• Prepare and submit GRAS and Food additive submissions to FDA, CFSAN and CVM.
• Work closely with ETA (Enzyme Industry Association), FDA, CVM, AAFCO, AFIA, state and national regulatory authorities to assure compliance with applicable laws and regulations for microbiologically - derived enzyme products, direct food ingredients and food and feed additives.
• Helped to influence developments in food and feed additive regulation in U.S. and Canada.

Honors & Publications

Publications

• Numerous publications; abstracts and peer-reviewed journals.

Education

• B.A. Biology, Indiana University, South Bend, IN