As global implications of nanotechnology continue to grow, so does commentary on how to regulate nanoscale materials in the United States. In the past quarter, many agencies pushed for expanded research and regulation of nanoscale materials, and two lawsuits now seek more regulation. Meanwhile, U.S. EPA continued to assert its authority under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) by issuing Significant New Use Rules (SNURs) for a variety of carbon nanotubes and fullerenes, and its first conditional approval of a nanosilver-containing pesticide product.
While the regulatory landscape for nanomaterials still is not clearly lit, movement toward further regulation continues to advance.
NNI Proposes Focused Nanotechnology Research.
In October 2011, the National Nanotechnology Initiative (NNI) issued its “Environmental, Health, and Safety Research Strategy” to identify and address the environmental, health, and safety research needs associated with nanotechnology. NNI identified six research categories to meet these needs:
- Nanomaterial Measurement Infrastructure
- Human Exposure Assessment
- Human Health
- Risk Assessment and Risk Management
- Informatics and Modeling
NNI’s report is meant to guide federal agencies as they produce scientific information in connection with risk management, regulatory decision making, product use, research planning, and public outreach.
ICTA Seeks to Force FDA Nanotech Regulation.
The International Center for Technology Assessment (ICTA) filed a December 21, 2011 complaint in the U. S. District Court for the Northern District of California. ICTA claims the Food and Drug Administration (FDA) violated the Administrative Procedure Act by failing to respond to the petition it had filed in 2006 to determine the scope of environmental and health impacts of nanomaterials and to invoke nanomaterialrelated labeling requirements in FDA-approved products. Arguing that there is enough scientific evidence of risk to warrant regulation of products containing nanomaterials, ICTA asserts that it is improper to infer the safety of products containing nanomaterials without first conducting additional testing.
EPA Proposes Significant New Use Rules for 14 Nanoscale Compounds.
On December 28, 2011, U.S. EPA issued for public comment proposed SNURs for 14 nanoscale compounds that were the subject of premanufacture notices, including seven substances with the term carbon nanotube and seven with the term fullerene in their names. The proposed rule advises potential Significant New Use Notice submitters that they will have a better chance of a favorable review if they include data regarding human exposure and environmental release that could result from use of the substance, its potential benefits, and the risks it poses compared to risks posed by potential substitutes.
EPA OIG Report Urges More Effective NanotechRegulation.
The U.S. EPA Office of Inspector General (OIG) issued a December 29, 2011 report titled “EPA Needs to Manage Nanomaterial Risks More Effectively” to address how well U.S. EPA is managing the human health and environmental risks of nanomaterials. The OIG report concluded that U.S. EPA lacks sufficient information and procedures to effectively manage risks associated with nanomaterials. It recommended that U.S. EPA develop a process to collect and share nanomaterial information across the agency, noting that adequate management of nanomaterials will depend on the effectiveness of the FIFRA and TSCA regulatory frameworks.
National Academy of Sciences Says More Nanotech Research Needed.
On January 25, 2012, an expert panel of the National Academy of Sciences (NAS) (sponsored by U.S. EPA) reported that there are “critical gaps” in the scientific community’s understanding of nanomaterials. The panel then proposed a research plan to identify potential nanomaterial releases, processes that impact exposure and hazards, nanomaterial effects from the subcellular to ecosystem- wide levels, and ways to accelerate research progress. NAS would require significant budgetary authorizations across several federal agencies to implement the plan.
EPA Approves Conditional Registration of First Nanosilver Pesticide.
U.S. EPA approved the first conditional registration of an antimicrobial nanosilver pesticide product for use on textiles, such as clothing and bed sheets, on February 22, 2012. Prior to this approval, the Natural Resources Defense Council (NRDC) expressed concerns that the toxicity of nanosilver has not been fully studied, and that U.S. EPA merely approved the conditional registration by relying on data “extrapolated” from tests that support re-registration. NRDC filed a lawsuit on January 26, 2012 to bar the then-pending conditional registration, and its appeal of the approval might serve as a litmus test for how U.S. EPA will proceed with conditional registrations of nanoscale compounds.