EPA Proposes Policy on Nanoscale Materials in Pesticide Products

The U.S. Environmental Protection Agency (EPA) released on June 9, 2011, a pre-publication copy of a forthcoming Federal Register notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act (PRIA), even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments will be due 30 days after the notice is published in the Federal Register.

OPP Considering Labeling of Nanopesticides

The State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee held a meeting on September 20, 2010. During the meeting, Jennifer McLain, Associate Director of the Antimicrobials Division, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), provided an update on EPA’s regulation of pesticides containing nanoscale materials. McLain’s presentation includes two previously unreported OPP regulatory activities. First, according to McLain, OPP intends to require that nanoproducts be labeled in the same way as other pesticide products. Ingredients would be listed as “nano-X,” and OPP would evaluate the claims on a case-by-case basis. Second, OPP apparently is considering issuing data call-ins to obtain information EPA may need to evaluate the registerability under FIFRA of nanoscale materials. Using its FIFRA data call-in authority is, of course, an option several industry groups have been urging in lieu of repurposing FIFRA Section 6(a)(2).

Plainly, OPP’s cryptic reference to FIFRA “nano labeling” requires far more explanation and some observers may find it disturbing. The presentation’s statement that “Nano-Products will be labeled the [sic] in the same way as other pesticide products” is, of course, ambiguous at best. Such an approach would lead to a number of important questions: What exactly is subject to labeling? Will the presence of any nanoscale material in a formulation trigger a nano label? How will confidentiality issues be addressed? The presentation raises other thorny issues, many of which appear to not have been publicly discussed.

EPA Chemical Enforcement Focuses on Nanoscale Materials Manufacturers

On March 30, 2010, Michael Bellot, Chief of the U.S. Environmental Protection Agency (EPA) Chemical Risk and Reporting Enforcement Branch, of the Office of Civil Enforcement, Waste and Chemical Enforcement Division, spoke at the Global Chemical Regulations Conference last week. Bellot described manufacturers of nanoscale materials as a “target-rich environment,” and stated that two-thirds of EPA’s 2009 chemical enforcement activity focused on nanoscale materials manufacturers. EPA did not go into detail on the scope of its enforcement activities, but suffice it to say entities that are engaged in nanoscale material manufacture and/or import should be mindful of this information.

EPA Clarifies Final CNT SNURs

On July 28, 2009, the U.S. Environmental Protection Agency (EPA) clarified its June 24, 2009, final Significant New Use Rules (SNUR) for multi- and single-walled carbon nanotubes (CNT).  According to EPA, upon review of the final rule, stakeholders asked whether the SNURs applied to all types of CNTs.  EPA responded:

 

This is not the case.  These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMN) submitted under Section 5 of TSCA and not to any other carbon nanotubes.  Other carbon nanotubes must be notified through EPA's New Chemicals Program.  The U.S. EPA strongly encourages all manufacturers and importers of nanoscale materials that are intended for commercial use to consult with the Agency in advance of production or importation.

EPA Unified Agenda Includes Item on Nanoscale Materials Stewardship Program

The U.S. Environmental Protection Agency’s (EPA) May 5, 2008, Unified Agenda includes an item regarding the Nanoscale Materials Stewardship Program (NMSP), which is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment. On January 28, 2008, EPA announced the NMSP. According to the Unified Agenda notice, EPA intends to publish in March 2009 an interim evaluation of the NMSP, and a final evaluation of the NMSP, “including next steps,” in April 2010.

EPA Unified Agenda Includes Item on Nanoscale Materials Stewardship Program

The U.S. Environmental Protection Agency’s (EPA) December 10, 2007, Unified Agenda includes a notice regarding the Nanoscale Materials Stewardship Program (NMSP), which is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment. On July 12, 2007, EPA announced the availability of an NMSP concept paper, a proposed information collection request (ICR), and a paper that describes determining the TSCA Inventory status of nanoscale materials. According to the Unified Agenda notice, EPA intends to publish in February 2008 a final NMSP notice, including final versions of any documents.

Pesticide Registration Applications Could Include Particle Size Information

As part of the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ (OPP) ongoing Nanotechnology Task Force Work, we understand that OPP is seriously considering revising the pesticide registration application form to require particle size information for both active ingredients and any inerts.