The Toxic Substances Control Act (TSCA) section 8(a) Nanotechnology Reporting and Recordkeeping Requirements Rule became effective on August 14. The rule establishes one-time reporting and recordkeeping requirements for certain chemical substances manufactured or processed at the nanoscale. To assist in compliance with the rule, the U.S. Environmental Protection Agency (EPA) issued a General guidance to assist in complying with EPA's Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.
This guidance provides detailed answers to 53 compliance questions on topics, including:
- What is reportable - specifically identifying unique and novel substance characteristics and the particle measurements for primary particles, aggregates and agglomerates;
- Who is required to report with definitions around processor responsibilities;
- Reporting timelines and schedules; and
- Confidentially, including how confidentially claims must be made.
The guidance was developed based on comments submitted to EPA by stakeholders during the public comment period. EPA expects there will be additional questions about compliance with the rule that a general guidance can’t address. Therefore, specific questions will be answered by EPA as they arise on a case-by-case basis, and the guidance will be revised to reflect the additional clarification provided by the agency.
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