Mark A. Hepp, Ph.D.
Mark Hepp, Ph.D., is a scientist with a background in chemistry and physics and an extensive record of government service at the U.S. Food and Drug Administration (FDA). He works closely with the firm's attorneys on technically complex matters serving a wide range of clients in food, food packaging, and allied industries. Mark typically serves clients involved in the development of new products and new markets for existing product lines.
Mark specializes in preparing risk assessments for regulated food additives, food packaging materials, and other food contact articles. He uses his extensive background in chemistry and physics to mathematically model complex processes used for preparing and packaging foods. He uses mathematical exposure modeling for grounding safety evaluations required for approval by global authorities, for preparing independent Generally Recognized as Safe (GRAS) determinations, and for documenting compliance with federal law and California's Proposition 65.
Prior to joining Keller and Heckman, Mark served for over 16 years as a Consumer Safety Officer in FDA’s Office of Food Additive Safety. His role at FDA involved evaluating safety data on food contact substances, integrating food additive technical reviews into Agency safety decisions, and advising stakeholders on the development of data packages. He also developed Agency guidance on many food additive issues, including approaches to the regulation of active food packaging materials, and the technical effects and jurisdictional issues relating to antimicrobial food additives. Mark also served as a member of the U.S. Delegation to the Codex Committee on Food Additives.
Keller and Heckman attorneys and clients rely on Mark’s extensive government experience, particularly in managing scientific, regulatory, and policy reviews for Food Additive Petitions (FAPs), Food Contact Notifications (FCNs), Threshold of Regulation (TOR) exemption filings, and GRAS notices. Additionally, Mark is a presenter at Keller and Heckman packaging seminars and is invited to speak at industry conferences.