Scott J. Burya, Ph.D.
Regulatory Chemist
T: 202-266-5013
F: 202-557-3836
Overview
Scott J. Burya, Ph.D. is a Regulatory Chemist with The Acta Group (Acta®). Dr. Burya has assisted in the preparation and submission of over 250 notifications to the U.S. Environmental Protection Agency (EPA) and commands a thorough and contemporary understanding of EPA’s review process for new chemicals under the Toxic Substances Control Act (TSCA). This specialized experience makes him an invaluable resource to assist clients in preparing robust and scientifically rigorous premanufacture notices (PMN) and low volume exemptions (LVE) and in determining whether and which exemptions under TSCA apply, such as the polymer exemption, the research and development (R&D) exemption, and exemptions in 40 C.F.R. Section 720.30. Dr. Burya has also developed tools for streamlining routine notifications to EPA, such as Bona Fide Intent to Manufacture or Import (BFI) notices and Chemical Data Reporting (CDR).
Dr. Burya’s experience extends to notifications to Environment and Climate Change Canada (ECCC), and Health Canada (HC) required under the Canadian Environmental Protection Act, 1999 (CEPA) and Canada’s Food and Drugs Act. Leveraging expert support from B&C’s toxicology team, Dr. Burya has assisted clients in identifying data for analogs and has developed waiver requests to address requirements for New Substance Notifications (NSN). Dr. Burya also assists clients in maintaining confidential information claims under the Hazardous Materials Information Review Act (HMIRA) and prepares Letters of No Objection (LONO) requests for food packaging materials.
Representative Engagements
- Developed waiver requests and identified data for analog substances for a hybrid inorganic-organic substance that addressed ECCC’s requirements for an NSN submission, saving the client significant time and cost to complete fate, aquatic toxicity, and health hazard testing.
- 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 an 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 a 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.
Professional and Community Involvement
- Member, American Chemical Society, 2010 – Present
- Inter-American Photochemical Society, 2011 – 2013
- Ohio State Science Fair Judge, 2011 – 2013
Articles and Writings
J. Brian Xu, M.D., Ph.D., DABT® and Scott J. Burya, Ph.D., “FCM regulations in China and the US – a comparison,” CW+ AsiaHub, July 18, 2018.
Palmer, A.M., Burya, S.J., Gallucci, J.C., and Turro, C. Photoinduced intercalation and coordination of a dirhodium complex to DNA: dual DNA binding. ChemMedChem 9(6), 1260-1265. 2014.
Sambasivan, R., Zheng, W., Burya, S.J., Popp, B.V., Turro, C., Clementi, C., and Ball, Z.T. A tripodal peptide ligand for asymmetric Rh(II) catalysis highlights unique features of on-bead catalyst development. Chemical Science. 5(4), 1401-1407. 2014.
Li, Z., Burya, S.J., Turro, C., and Dunbar, K.R. Photochemistry and DNA photocleavage by a new unsupported dirhodium(II,II) complex. Philosophical Transactions. Series a, Mathematical, Physical and Engineering Sciences. 371:2012.0128. 2013.
Presentations
“Keeping up with FSMA – Rules, Obligations, and Key Compliance Dates,” Bergeson & Campbell, P.C. (October 17, 2018).
“Photoinduced ligand exchange and covalent DNA binding by two new dirhodium acetamide complexes,” Burya, S.J., Gallucci, J.C., and Turro, C., 243rd ACS National Meeting (2012).
“Photoinduced Ligand Exchange and Covalent DNA Binding by Two New Dirhodium Acetamide Complexes,” Burya, S.J., Gallucci, J.C., and Turro, C., Pittcon Conference and Expo (2012).
“The Photochemistry and DNA Binding of Novel Inorganic Complexes,” The Ohio State University, Hayes Forum (2012).
