Little Pro on 2016-05-10
In the US, there is no federal or state legislation specific to nanomaterials. Nanomaterials are managed by current regulatory framework for chemicals, pesticides, food, cosmetics and drugs. The main authorities involved are the EPA and FDA. In this article, we will focus on the Toxic Substance Control Act (TSCA) and nanomaterials.
Nanomaterials are regarded as "chemical substances" under the TSCA. TSCA requires manufacturers of new nanomaterials to submit a pre-manufacture notice to the Agency prior to manufacturing or importing them.
In determining whether a nanoscale substance is a new or existing chemical substance, the EPA check if its molecular identity is listed in TSCA inventory, rather than focus on physical attributes such as particle size [Reference].
For some existing nanomaterials (i.e., multi-walled carbon nanotubes), the EPA issued Siginificant New Use Rules (SNURs). All those nanomaterials are required t be notified to the Agency individially like new substances/nanomaterials.
For other and all existing nanomaterials, EPA plans to impose reporting and record-keeping requirements on the manufacturers (including importers) of nanomaterials.
In 2015, EPA proposed new rules according to TSCA section 8(a) to require reporting and recordkeeping information on certain chemical substances when they are manufactured or processed as nanoscale materials.
This proposed rule would require that companies that manufacture certain chemical substances already in commerce as nanoscale materials notify EPA of information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data.
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