Nanoscale materials used in everything from food packaging to industrial chemicals to medical devices may soon be regulated by the Environmental Protection Agency in the US, and by other regulatory bodies in Europe and Japan.
The EPA has proposed mandatory reporting rules for nanomaterials under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and is developing comprehensive regulations under the Toxic Substances Control Act (TSCA). The TSCA regulations would include four areas: premanufacture notification, a Significant New Use Rule (SNUR), an information gathering rule, and a test rule.
But a recent report by the EPA's Office of Inspector General (OIG) found "that EPA does not currently have sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials." The report says that, although the EPA has the statutory authority to regulate nanomaterials, at present it "lacks the environmental and human health exposure and toxicological data to do so effectively."
Even if mandatory reporting rules for nanomaterials are approved, says the report, the effectiveness of the EPA's ability to manage nanomaterials risks remains in question for four main reasons. These are: the lack of a formal process for coordinating and disseminating mandated information; the lack of an overall message to external stakeholders about policy changes and risks; regulating nanomaterials as chemicals will be limited by the limitations of existing statutes; and a lack of information about risks and a reliance on industry-submitted data.
In the report, the OIG recommends that "the Assistant Administrator for Chemical Safety and Pollution Prevention develop a process to assure effective dissemination and coordination of nanomaterial information across relevant program offices." The report also states that the EPA agreed with its recommendation and provided a corrective action plan. By January 31, 2012, the EPA is to convene a workgroup to begin development of this process, and by July 31, 2012, the EPA will complete a draft document outlining the process.