Originally published on The Nano Newswire
The Nano Newswire reported last October that EPA intended to use section 6(a)(2) of FIFRA, the Federal Insecticide, Fungicide, and Rodenticide Act to require pesticide manufacturers to identify nanomaterials in the pesticides as an "adverse effect." Last week EPA announced two alternate proposals for collecting data about nanoscale materials in pesticide products as well as a new method for determining whether a nanoscale material is "new" under FIFRA and the Pesticide Registration Improvement Act. The Federal Register notice was published on Friday, June 17, 2011.
One approach to data collection would rely on section 6(a)(2) of FIFRA, which requires registrants to disclose additional factual information regarding adverse effects on the environment from the pesticide. Existing registrations would have to be updated to include disclosure of the presence of nanoscale materials, and new applicants would be required to include the information. Section 6(a)(2) imposes a continuing obligation and the onus would be on registrants to get the data to EPA. EPA does not see the inclusion of nanoscale materials as an expansion of its interpretation and it would not plan to change its regulations. It rejects the idea that 6(a)(2) reporting will create a stigma for the nanotechnology industry and counters that a wide range of information related to the risk/benefit evaluation of pesticides must be disclosed.
As an alternative to 6(a)(2) reporting, EPA is considering the use of data call-in notices ("DCIs") under section 3(c)(2)(B) of FIFRA. EPA would issue notices to individual registrants seeking specific information. This route is less desirable for EPA as it would likely result in higher administrative costs. Further, its not clear how the agency would handle the addition of nanoscale material disclosure in new registrations, or update the information obtained through an initial DCI.
EPA is also considering applying an initial presumption that nanoscale material in a pesticide registration application is "new" even when the same ingredient is in another registered product but it is a different size, whether it be non-nanoscale, or nanoscale with different dimensions or properties. The applicant could rebut the presumption that the material is new by proving the material is substantially similar to a registered material and will not significantly increase the risk of unreasonable adverse effects on the environment. Whether a material is new or a "me-too" application effects the timeframes for EPA to approve applications and could delay registrations for pesticides with nanoscale material.
EPA is seeking comments until July 18, 2011.
www.daypitney.comThe content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
