FIFRA/Nanotechnology:Guest Column: Kathryn Brausch & Irene Hantman Law Clerk & University of Maryland Law Fellow US EPA Office of Civil Enforcement
Readers interested in EPA’s regulation of nanoscale materials may want to know about recently proposed policies under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that would affect the use of nanoscale materials in pesticide products.
On June 17, 2011, EPA published a Federal Register notice (76 FR 35383), requesting comments on two alternative approaches for obtaining information on nanoscale materials, both active and inert ingredients, used in currently registered pesticide products. The Agency also requested comments on a proposal that would affect the classification of registration applications for pesticide products containing nanoscale materials. An overview of these proposals, and a summary of their scientific basis, is set out below.
The Scientific Basis
In the Federal Register notice, the Agency reviews the growing body of scientific evidence concerning the human health and environmental hazards of certain nanoscale materials, some of which are used in pesticide products. After reviewing the evidence, EPA concludes that it indicates that significant differences exist between many nanoscale materials and their non-nanoscale counterparts. Although some of the differences have beneficial applications, some of them pose new or increased hazards. EPA reasons that these potential “new” hazards warrant further regulatory scrutiny.
The Alternatives for Collecting Information
The scientific evidence has led EPA to conclude that collecting information from registrants of existing pesticide products is relevant to the Agency’s statutory obligation. Under FIFRA, EPA has a statutory obligation to determine whether the registration and use of a pesticide may cause unreasonable adverse effects on the environment or human health. This finding is required for “each and every pesticide product, regardless of whether another pesticide product with the same or similar composition and use patterns is already registered.” Thus, according to EPA, the presence of a nanoscale material in a pesticide formulation provides a sufficient basis for the Agency to request additional information that may be used to characterize potential risks that may not have been considered when the pesticide was originally registered. Although the presence of nanoscale materials is sufficient to justify the proposed requests for information, the Federal Register notice stresses that the presence of a nanoscale material is not, by itself, an indicator of potential adverse effects. However, EPA will use the information it receives from registrants to assess whether additional data are necessary to support continuing the registration and whether amending a registration is necessary to prevent such adverse effects.
According to the proposed policy, EPA would use one of the two alternative processes summarized in the bullet-points below to collect the data and other information needed. The process would apply to both active and inert nanoscale ingredients.
— Under one alternative, EPA would formally announce that ‘reportable’ information required under FIFRA §6(a)(2) includes information on the presence of nanoscale materials. Following the formal policy announcement, any registrant with such information would have 30 days to submit it to EPA. Specifically, each registrant that knew it had a registered product containing a nanoscale material would provide existing information concerning: (1) the identity of the affected product; (2) the identity of the nanoscale materials in the product; (3) the size or size distribution of the nanoscale materials; (4) the manufacturing process used to produce them; (5) the size and size distribution of the composite matrix, if any, containing the materials; and (6) the data showing adverse effects at any level of exposure, and the nature and levels of human and environmental exposure. This alternative has proven controversial because section (6)(a)(2) concerns “adverse effects” reporting – members of the nanotechnology community therefore worry that use of this section would create a stigma for all nanoscale materials used in pesticide products.
— Under a second alternative, EPA would issue data call-ins under FIFRA §3(c)(2)(B) to specific groups of registrants. The scope of information collected would potentially be the same under this alternative as it would be under the other one, but registrants would be given 90 days to respond. EPA could also request the generation of new data and information, which it cannot request under the other alternative. Moreover, the burden on industry and EPA would increase. Typically, registrants that receive such data call-in requests are required to respond even when they don’t have the requested information. And EPA would have to track its requests to identify non-responders warranting enforcement.
Under either alternative, EPA would use the information it received to determine whether additional data needs to be generated or whether a registration should be cancelled or amended to prevent unreasonable adverse effects.
The New Classification of Applications
EPA also announced a policy affecting the classification of applications seeking to register pesticide products containing nanoscale materials. Under the new approach, EPA would presume that active or inert nanoscale ingredients are potentially different from non-nanoscale versions of those ingredients that were previously registered. EPA also would presume that one nanoscale version of an ingredient is potentially different from another, already-registered nanoscale version of the same ingredient. Based on these presumptions, EPA would initially classify all such applications as applications for “new” ingredients, increasing the application fee, the time EPA has to review the application, and the amount of information it may require. An applicant could overcome the presumption by proving that the nanoscale version to be registered is sufficiently similar to the registered version or differs only in ways that do not significantly increase the risk of unreasonable adverse effects or require different registration terms or conditions. If successful, EPA would review the application in a shorter timeframe and allow the applicant to rely on the data from the previous registrant, subject to appropriate compensation where required.
This proposed policy also has significant compliance implications. Specifically, a company would potentially violate the registration requirements by substituting nanoscale ingredients for non-nanoscale ingredients without first notifying EPA and receiving Agency approval. Assuming the policy is finalized, it is clear that substitutions occurring after the policy announcement would face a significantly increased risk of having violated the registration requirements. However, the Federal Register notice is less clear with respect to the legal implications of substitutions that occurred before announcement of the new policy — such substitutions might be considered potential violations of the registration requirements or the section 6(a)(2) reporting requirements.
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Once adopted, the policies announced in the above-cited Federal Register notice are likely to be the first of many policies EPA develops to address the use of nanoscale materials in consumer products and other product types. Accordingly, those using such materials should be prepared for additional inquiries about their use of such materials and their potential effects.
DISCLAIMER: This work is not a product of the United States Government or the United States Environmental Protection Agency. The views expressed are those of the authors only and do not necessarily represent those of the United States or the US EPA.