Scott J. Burya, Ph.D.
Regulatory Chemist
 

 
T: 202-266-5013
F: 202-557-3836
 
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EDUCATION:

BS, Ohio University, Chemistry (Physical) cum laude, 2007

MS, Ohio State University, Chemistry (Analytical), 2009

Ph.D., Ohio State University, Chemistry (Analytical),  2013

 
RANKINGS & RECOGNITION:

Henne Graduate Research Competition Award, 2012

Edward R. Grilly Scholarship, 2007 - 2008

 

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Scott J. Burya, Ph.D. is a Regulatory Chemist with Bergeson & Campbell, P.C. (B&C®). Dr. Burya supports clients in all stages of product development, from assessing the toxicology and regulatory profiles of new substances, performing quantitative risk assessments, and navigating state and federal regulations, to guiding teams through complex submission processes. His areas of expertise include the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Federal Food, Drug, and Cosmetic Act (FFDCA), regulation of chemicals under California’s Proposition 65 (Prop 65), and the transport of hazardous materials under Title 49 of the Code of Federal Regulations.

Before joining B&C, Dr. Burya held progressively senior positions in Product Safety and Regulatory Affairs for a multinational chemical company where he managed teams and processes that addressed the requirements set by the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), the U.S. Department of Transportation (DOT), Environment and Climate Change Canada (ECCC), Health Canada (HC), and other agencies. Notably, he led multidisciplinary teams comprised of chemists, toxicologists, and third-party labs focused on clearing new technologies, and has obtained Premanufacture Notices (PMN), Food Contact Notifications (FCN), New Substance Notifications (NSN), and other agency approvals required to commercialize products.

Representative Engagements:

  • Addressed issues raised by EPA during the review of a TSCA PMN by refining exposure estimates and identifying appropriate hazard data, resulting in a “not likely to present an unreasonable risk” determination with no TSCA restrictions.
  • Assisted a start-up company to address EPA’s concerns and obtain a low volume exemption (LVE) needed to commercialize a novel nanomaterial product.
  • Specified testing needed to address food contact regulations in the United States and the European Union for a new coating product and evaluated the resultant migration data against applicable regulatory limits.
  • Prepared argument elaborating the chemical identity of a product flagged during a compliance inspection demonstrating that no TSCA violation occurred.
  • Assisted client in determining that a key monomer was listed on the confidential portion of the TSCA Inventory, allowing the associated polymer to be eligible for the polymer exemption.

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