Formation / History

Those working with biomaterials, including researchers, scientists, regulatory and government officials and related organizations and industry professionals are under increasing scrutiny due to rising anxiety associated with the hazards inherent in their work and the products they produce. Topics ranging from the production and safety of pharmaceuticals to the research, development and distribution of microorganisms, stem cells and toxins are headline news. This turbulent environment reinforces the need for standards to address these and other areas of pressing public concern.

The Expert Panel for the Development of Standards for Biodefense hosted by ATCC® on April 4-5, 2006 firmly established the need for development of material and process standards for biodefense. The inadequacy of existing regulation and the need for standards-based oversight are continually reinforced by current events. Most attendees of the Expert Panel and government agencies supported standards as a means to assure quality and protect the development, distribution, storage and application of biological materials and processes used for biodefense.

To build on the momentum generated by the Expert Panel and expedite the development of these standards, ATCC® formed the Consensus Standards Partnership (CSP) as the consensus body for the ATCC® SDO. The objective of the ATCC® SDO is to formally develop industry-relevant national consensus standards aligned with established national professional and International Standards Organization (ISO) requirements.

Membership in the ATCC® SDO is open to all stakeholders. Stakeholders include, but are not limited to all personnel involved in the production, application and regulation of biomaterials such as contractors, scientists and researchers from the academic, government, military, regulatory, and industry sectors.