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Evaluating Novel Products under Existing Regulations

Regulatory frameworks associated with chemicals and products are generally constructed to address clearly identified substances, known products, and conceivable end uses. Unfortunately, variations that may arise from evaluating nanomaterials, substances of unknown or variable composition (UVCB substances), or novel product types with end uses not considered during the development of those rules and regulations can lead to challenges in meeting applicable obligations. To adequately address these challenges, an extended time from project initiation to regulatory approval as well as expenses associated with data generation and other required tasks often ensue. Companies find themselves setting precedents for agency negotiations and working with laboratories on method development. Real world examples related to the topic will be presented to provide attendees with strategies and solutions when presented with such a situation.

Presenter(s): Maryann Sanders, Senior Regulatory Compliance Specialist, Haley & Aldrich, Mark Jackson, Senior Toxicologist, Haley & Aldrich

Presentation Date: 11/3/2017

Contact Hour(s): 1.0



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