Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > EPA Closing in On Nanopesticide Reporting Policy
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Lynn L. Bergeson Managing Director Bergeson & Campbell, P.C. |
Abstract:
About a year ago, the U.S. Environmental Protection Agency (EPA) announced its intent to adopt a policy presuming that an active or inert ingredient will be considered "new" under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) if the ingredient is or contains a "nanoscale material" and requiring any registrant of a pesticide product registered under FIFRA that is aware the product contains a nanoscale material to submit the information to EPA pursuant to FIFRA Section 6(a)(2). The "classification" policy came as no surprise and many believe it reflects a legally defensible interpretation of FIFRA. The "reporting" policy, however, was greeted with immediate and strong resistance. A logical inference of EPA's new reporting policy is that EPA must regard the mere presence of a nanoscale material to be "adverse" since EPA regulations generally limit the obligation of a registrant to report information pursuant to FIFRA Section 6(a)(2) to information that concerns "adverse effects."
April 29th, 2011
EPA Closing in On Nanopesticide Reporting Policy
About a year ago, the U.S. Environmental Protection Agency (EPA) announced its intent to adopt a policy presuming that an active or inert ingredient will be considered "new" under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) if the ingredient is or contains a "nanoscale material" and requiring any registrant of a pesticide product registered under FIFRA that is aware the product contains a nanoscale material to submit the information to EPA pursuant to FIFRA Section 6(a)(2). The "classification" policy came as no surprise and many believe it reflects a legally defensible interpretation of FIFRA. The "reporting" policy, however, was greeted with immediate and strong resistance. A logical inference of EPA's new reporting policy is that EPA must regard the mere presence of a nanoscale material to be "adverse" since EPA regulations generally limit the obligation of a registrant to report information pursuant to FIFRA Section 6(a)(2) to information that concerns "adverse effects."
EPA forwarded the policy to the Office of Management and Budget (OMB) for review last July. Stakeholders met with OMB to express their extreme displeasure with the reporting policy and argued: the reporting policy will stigmatize all uses of nanotechnology in pesticides; EPA failed to define "nanoscale material" sufficiently for regulatory purposes; the policy will adversely impact trade as products treated with nanopesticides could be considered "tainted" and thus at risk of rejection in certain markets; and the policy will not elicit the type of information EPA needs for risk characterization purposes.
Most stakeholders support EPA's interest in obtaining information about the possible presence of nanoscale materials in a pesticide formulation and the impact, if any, of this fact on the risk profile of the pesticide product. FIFRA contains provisions expressly authorizing EPA to obtain information from registrants, and many have urged EPA to utilize these provisions to fulfill the same goal, but to do so with less negative impacts on nanotechnology.
Recent Update
At a recent trade association meeting in Washington, D.C., EPA stated that it expects to release soon its "draft policy proposal." As outlined at the April 8 conference, the new policy will contain two components, as EPA previously reported. As for the pesticide classification component, EPA will presume an active or inert ingredient will be considered "new" if the ingredient is or contains a nanoscale material. This could be the case even when a non-nanoscale form of the same active or inert is already in a registered product. EPA specifically noted that nanosilver would be considered new even though silver is a registered pesticide.
As for the reporting obligation component, under FIFRA Section 6(a)(2), registrants and pesticide applicants must report to EPA information on the presence of nanoscale materials in products. Under this policy, registrants and applications must report 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. Only existing information known to the company is reportable.
EPA also stated that it anticipates implementing further reporting obligations with respect to nanopesticide products. Specifically, EPA stated that it intends this calendar year to seek additional data on all products with nanoscale materials through its FIFRA data call-in authority, to evaluate data needs on a case-by-case basis, and to assess data needs according to composition of the product and its intended use.
If indeed EPA intends to propose this new policy interpretation, this is an improvement over EPA's earlier plan of issuing a new reporting policy in final. This change alone, although welcome, fails to address the substantial problems with the proposal -- the stigmatizing impact of the "adverse" label, the potential fear it invites concerning all things nano, and the adverse impact it could have on trade, among other issues identified to date.
Nano stakeholders remain committed to ensuring that EPA fully appreciates the potential and irrevocable damage it could cause by interpreting FIFRA Section 6(a)(2) to require that registrants report to EPA information on the presence of nanoscale material in pesticide products. The hope is EPA has heard these concerns, and will address them to avoid the stigmatizing impact an "adverse effect" reporting implication would have on nanopesticides. If EPA issues the draft reporting policy as outlined above without significant change, the public comment process will provide a critically important opportunity to disabuse EPA of its belief adverse effects reporting will have no impact on nanopesticides.
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