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September 29, 2010

OPP Considering Labeling of Nanopesticides

The ACTA Group

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 slides are available online.

Much of the information presented was similar to the update William Jordan, OPP, provided to the Pesticide Program Dialogue Committee at its April 29, 2010, meeting. (See online.) McLain reported that OPP is still preparing its response to the May 2008 petition from the International Center for Technology Assessment, which urged EPA to regulate nanosilver products as pesticides. During the SFIREG POM Committee meeting, McLain reiterated that while several currently registered pesticides claim to contain nanoscale materials, these products were registered without EPA’s knowledge of nanoscale materials in the products. To date, EPA reportedly has held pre-application meetings concerning nanopesticides, and several of the pending registration applications concern nanosilver.

McLain summarized OPP’s 2009 consultation with the Scientific Advisory Panel on how to assess risks of products containing nanoscale silver. According to McLain, OPP is continuing to draft a new interpretation of FIFRA Section 6(a)(2) regulations. The new interpretation will be that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). This policy would apply to an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between one and 100 nanometers. OPP also intends to memorialize its view that an active or inert ingredient would be considered “new” if it is a nanoscale material. The new policy would apply even when a non-nanoscale form of that same active or inert is already in a FIFRA-registered product.

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.

This OPP initiative appears to be the U.S. government’s initial foray into the controversial area of mandatory nano labeling. It is not clear why OPP appears to have broached such an important issue for the first time publicly in a presentation at a SFIREG meeting and apparently with little or no prior outreach to stakeholders. This will likely be the subject of expressions of continued concern from industry stakeholders who have been already concerned with what they believe is largely a dearth of public process on the labeling issue, a result that they believe remains a far cry from the Administration’s commitment to transparency and public participation.