The U.S. Environmental Protection Agency ("EPA") recently published a notice proposing and seeking comment on potential approaches to addressing nanoscale materials in pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA").1 EPA is proposing policies related to obtaining information about the presence of nanoscale materials as well as how to determine whether a nanoscale substance is to be considered "new" under FIFRA, even if it is a nanoscale form of an already registered ingredient. EPA's actions are in response to a growing body of scientific evidence demonstrating that nanoscale materials exhibit different properties from non-nanoscale materials of the same substance and that such differences potentially could have toxicological relevance.
The proposal would require existing pesticide registrants and applicants for new pesticide products to disclose information that would enable EPA to determine if the presence of nanoscale materials would cause unreasonable adverse effects on the environment. While at this time EPA is only seeking information on which to base future regulatory decisions, existing and future registrants using nanoscale materials in their products can expect an increased burden in demonstrating the safety of their products. Interested parties may comment on EPA's proposal by August 17, 2011.
First Time Regulatory Definition for Nanoscale Ingredients
In the proposal, EPA for the first time offers a regulatory definition of a "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." EPA proposes to consider a nanoscale material as "intentionally produced" if the manufacturing process uses techniques specifically intended to create or enhance the proportion of nanoscale materials in the product. EPA expects this definition to include nanoscale forms of metals and carbon-based materials, including nano-silver and carbon nanotubes, but not "biological" materials or materials that are naturally in nanoscale form.
EPA seeks comment as to whether its proposed definition of nanoscale materials is appropriate, including whether it is appropriate to distinguish between naturally occurring and intentionally produced nanoscale materials. EPA also seeks comment on whether the reporting requirement should only apply to a threshold percentage of nanoscale materials in an ingredient, and, if so, at what threshold the reporting requirement should apply.
Information Requested by EPA
EPA proposes to require the reporting of information regarding the presence of nanoscale materials in pesticides, whether as active or inert ingredients, if such materials are intentionally produced. EPA emphasized that the existence of nanoscale materials is merely grounds for making potential further inquiries into adverse effects on the environment. EPA stressed that providing the requested information will not impact the registration status of currently registered products containing nanoscale materials. If EPA later determines that a risk is associated with the use of a particular nanoscale material, it would conduct a separate action under existing FIFRA regulations to either cancel or add conditions to the registration of the pesticide.
In addition to information regarding the presence of nanoscale materials, EPA also proposes to require the reporting of any other information that may be relevant to determining whether a pesticide causes unreasonable adverse effects on the environment. EPA considers information relevant to determining adverse affects to be broader than information directly concerning adverse affects. Examples of information EPA considers responsive includes, but is not limited to, the following:
- Any existing information that shows adverse effects at any level of exposure to the nanoscale material on humans or other nontarget species.
- Existing information characterizing the size and size distribution of the nanoscale material.
- Existing information that describes the nanoscale manufacturing process.
- If the nanoscale material is used in a formulation that contains a composite, any existing information that characterizes the size and size distribution of the composite.
EPA proposes using one of two alternative provisions of FIFRA to obtain the information: the general "adverse effects" reporting obligation under Section 6(a)(2) or the "Data Call-In" ("DCI") provisions of Section 3(c)(2)(B). Under Section 6(a)(2), EPA would establish a new class of information considered relevant to assessing adverse effects and require any applicant or registrant to provide EPA with existing information in its possession. Registrants or applicants without relevant information would not be required to respond, and EPA would have no authority to require the collection of data without further regulatory action. The Section 6(a)(2) approach would be the least burdensome for EPA and is thus the Agency's preferred approach.
Under the alternative DCI approach, EPA would send information requests directly to individual pesticide registrants. As DCIs only apply to existing registrants, EPA also would take steps to require applicants to provide similar information. Because EPA has no means of determining whether nanoscale materials are present in pesticides, all pesticide registrants could potentially receive the DCI and be required to respond, regardless of whether nanoscale materials are present in their products. EPA is requesting comment on potential techniques for making the DCI process less burdensome in this context, including not requiring a response and targeting DCIs only on certain classes of pesticides likely to contain nanoscale materials. Notably, the DCI approach would allow EPA to require the generation of new data, although EPA indicated in the proposal that under either of the proposed approaches any new data required would be the subject of a subsequent DCI.
EPA's Proposed Policy for Treatment of Nanoscale Materials as "New Ingredients"
Under existing FIFRA regulations, registration of pesticides using the same ingredients and having the same targeted use as a currently registered pesticide is streamlined through the "me-too" registration provisions under FIFRA Section 3(c)(7). Under those provisions, EPA will register identical or substantially similar products as long as the use patterns and the chemical structure and composition of the products are similar. EPA previously has not considered the size of the ingredients to be relevant in this assessment.
EPA's proposed policy would create a presumption that a pesticide containing a nanoscale ingredient is different than a currently registered pesticide containing a conventional version of the same ingredient (e.g., non-nanoscale silver). Thus, EPA would classify, at least initially, applications for nanoscale ingredients as applications for new active or inert ingredients. This presumption could be rebutted if an applicant could demonstrate that the nanoscale form of an ingredient does not have different properties from the conventional ingredient, or that the properties differ in ways that would not pose a significant risk of unreasonable adverse effects. If the applicant could not make such a showing, EPA would process the application as a registration for a new ingredient, a more lengthy process that typically requires submission of data assessing hazards and exposure levels.
EPA requests comments regarding the kind of information that would demonstrate that a product containing a nanoscale ingredient is identical or substantially similar to a currently registered product, or that the nanoscale material only differs in ways that do not implicate adverse impacts on human health or the environment.
EPA's data collection effort and proposed policy statement indicate that the agency is increasingly interested in the potential adverse health impacts of nanoscale products. While EPA acknowledges that the proposed policy on new ingredients is guidance and not legally binding, regulated parties should expect EPA to follow the policy under most circumstances. Although the reporting of existing information on nanoscale materials that is already known to registrants and applicants may not be a large burden, more burdensome data collection requirements likely will follow. In addition, EPA's policy announcement regarding the treatment of new materials will create substantial hurdles to the registration of pesticide products that use nanoscale forms of ingredients already approved by EPA. Accordingly, manufacturers of pesticide products that contain or in the future may contain nanoscale ingredients should consider submitting comments in response to the EPA notice.
With the explosion of consumer interest in all things antimicrobial, many companies are seeking to tout the ability of their products to kill or resist bacteria. In doing so, these companies trigger, often unwittingly, the pesticide registration requirements of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). In response, the EPA has focused enforcement resources on prosecuting companies that market products that have not obtained an EPA registration in advance. Further, with the proliferation of products with dubious antimicrobial benefits, EPA regulators are initially skeptical of applicants for registration. We help clients navigate FIFRA's maze of regulatory and data requirements. Our familiarity with the relevant EPA regulators adds an important level of credibility to our service. Accordingly, manufacturers of pesticide products that contain or in the future may contain nanoscale ingredients should consider submitting comments to EPA by the (recently extended) August 17th deadline."