While EPA has yet to issue formal definitions for terms such as nanotechnology or nanoscale materials under any statute, the Agency understands those terms in the context of three conditions or elements:
- The material’s particle size measures typically between approximately 1 and 100 nanometers in at least one dimension.
- The material exhibits unique or novel properties compared to larger particles of the same material.
- Rather than occurring naturally, the material has been manufactured or engineered at the nanoscale to take advantage of these unique properties.
According to the proposed policy, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides EPA with two tools to collect a wide range of information about existing and new pesticides. Under FIFRA Section 3(c)(2)(B), the Agency may execute a data call-in (DCI) notice to require any registrant of a pesticide to provide data about a product for any of a variety of reasons, including as part of either the registration review program or the special review program. Under FIFRA Section 6(a)(2), registrants must inform EPA of relevant information related to their products even if it was not specifically requested by EPA. In the proposal, EPA expresses a preference for Section 6(a)(2), which it views as the more efficient and expedient administrative approach to obtaining information about nanoscale ingredients in pesticides.
Same Material, Different Properties
The policy discusses numerous aspects of nanomaterials, which have produced new regulatory and policy issues. Mainly, many researchers hold that nano-scale particles in a material have chemical and physical properties that differ from larger particles comprising the same material. As a result of their size and composition, nanomaterials have the potential to be more interactive or durable than other chemicals. Specifically regarding pesticides, EPA recognizes that the use of nanoscale materials may allow for more effective targeting of pests, use of smaller quantities of a pesticide, and less frequent spray-applied surface disinfection. These attributes could contribute to improved human and environmental safety and could lower pest control costs.
EPA is also cognizant of opinions expressed by a number of well-regarded organizations that the small size of nanoscale materials or their unique or enhanced properties may, under specific conditions, pose new or increased hazards to human health and the environment. For example, EPA cites a 2009 report by the National Institute of Occupational Safety and Health (NIOSH), which noted research indicating that airborne nanomaterials have the greatest potential to enter the body through the respiratory system. The Agency also points to a report by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), which wrote, also in 2009, “For some nanomaterials, toxic effects on environmental organisms have been demonstrated as well as the potential to transfer across environmental species, indicating a potential for bioaccumulation in species at the end of at that part of the food chain.”
In addition, in its proposed policy, EPA acknowledges that nanoscale materials may also have properties that make them less risky that than larger size materials or particles of the same substance. “Thus, EPA does not regard the fact that an ingredient meets our description of a nanoscale material as evidence that a pesticide containing the ingredient would cause unreasonable adverse effects on the environment and thus would no longer meet the statutory standards for registration,” states the Agency.
In the context of FIFRA, EPA is obligated to determine through the collection and assessment of data whether pesticidal products meet the statutory standards for registration. With respect to nanomaterials in pesticides, such information would include whether the nanomaterial is an active or inert ingredient; the size and size distribution of the material; the manufacturing process used to produce the material; and adverse effects at any level of exposure on humans or nontarget species.